title: Simulation of Stent-graft Deployment in Aortic Arch Aneurysms

summary: Total endovascular repair of the aortic arch represents a promising option for patients ineligible to open surgery. Custom-made design of stent-grafts (SG), such as the Terumo Aortic® RelayBranch device (DB), requires complex preoperative measures. Accurate SG deployment is required to avoid intraoperative or postoperative complications, which is extremely challenging in the aortic arch. In that context, our aim is to develop a computational tool able to predict SG deployment in such highly complex situations. Four patient-specific cases will be performed with complete deployment of the DB and its bridging stents in aneurysmal aortic arch. Deviations of our simulation predictions from actual stent positions will be estimated based on post-operative scan and a sensitivity analysis will be performed to assess the effects of material parameters. If good agreement between simulation and reality is obtained, numerical simulations will show their ability to successfully predict the DB deployment in complex anatomy. The results will emphasize the potential of computational simulations to assist practitioners in planning and performing complex and secure interventions.

location_country: France Netherlands

location_facility:
Rinjstate Hopital
CHU Saint-Etienne


design_allocation: Randomized

intervention_type: Drug

status: Not yet recruiting

study_start_date_type: Anticipated

study_type: Interventional

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Norway
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Ireland
China
Portugal
United States
Germany
United Kingdom
Italy
Austria
Czechia
Israel
Spain
Turkey

acronym: EXCALIBER-RRMM

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: West Penn Allegheny Lupus Center of Excellence

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Centro Hospital e Universitario de Coimbra

location_facility: Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu

location_facility: Arcispedale Santa Maria Nuova - AUSL Reggio Emilia

location_facility: Beijing Chaoyang Hospital Capital Medical University

location_facility: Memorial University of NewfoundlandDr. H Bliss Murphy Cancer Center

location_facility: Ondokuz Mayis University Medical Faculty

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin

location_facility: Florida Cancer Specialists North Region Sarah Cannon Research

location_facility: Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal

location_facility: Chang Gung Medical Foundation, Kaohsiung Memorial Hospital

location_facility: University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: The Catholic University of Korea Seoul - Saint Mary's Hospital

location_facility: Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Severance Hospital, Yonsei University Health System

location_facility: ASST Grande Ospedale Metropolitano Niguarda, Milano

location_facility: Ruijin Hospital Shanghai Jiaotong University

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Hospital Center of Lisbon North E.P.E - Hospital Pulido Valente

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

location_facility: Instituto Portugues de Oncologia de Lisboa, Francisco Gentil

location_facility: Summit Medical Group Overlook Oncology Center

location_facility: Klinikum der Johann Wolfgang Goethe Universitat

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliera S. Andrea - Università La Sapienza

location_facility: Kantonsspital St. GallenBereich OnkologieHamatologie

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Hospital Universitario Central de Asturias

location_facility: Ipo Instituto Portugues De Oncologia Porto

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Hospital Universitario Vall D hebron - PPDS

location_facility: The First Affiliated Hospital of Medical School of Zhejiang University

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Università di Catania- Presidio Ospedaliero Ferrarotto

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Chang Gung Medical Foundation, Linkou Memorial Hospital

location_facility: The First Affiliated Hospital of Harbin Medical University

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

location_facility: Sahlgrenska University Hospital Department of Hematology and Coagulation

location_facility: State Institution Hematological Research, Centre of Russian Academy of Medical Science

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hwasun Chonnam National University Hospital

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Universitario de Salamanca - Hospital Clinico

location_facility: Oxford University Hospitals NHS Foundation Trust-Churchill Hospital-Cancer and Haematology Centre

location_facility: New York - Presbyterian/Weill Cornell Medical Center

location_facility: Specjalistyczny Szpital im. dra Alfreda Sokolowskiego

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: Uniwersytet Jagiellonski Collegium Medicum

location_facility: Flinders Medical Centre, Dept Of Oncology

location_facility: CHU de Nancy - Hopital Brabois- Service d'Hematologie et DE medecine Interne, 7eme etage

location_facility: Institution of Hematology & Hospital of Blood Disease, Chinese Academy of Medical Sciences

location_facility: Shengjing Hospital Of China Medical University

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: Other Identifier

type: EudraCT Number

source: euctr

title: A Phase 3, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)

summary: This is a multicenter, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

summary: This is a Phase 3 trial to evaluate the efficacy and safety of 30 mg/kg intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.

study_start_date_type: Actual

status: Recruiting

lead_sponsor: FibroGen

location_country:
Italy
Brazil
Peru
Serbia
Lebanon
Mexico
Netherlands
Dominican Republic
Czechia
France
Poland
Georgia
Hungary
Spain
Denmark
Germany
United Kingdom
Colombia
Ukraine

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos LTDA EPP

location_facility: Rafik Hariri University Hospital (Clinical Research Unit)

location_facility: Municipal Institute for Lung Diseases and Tuberculosis

location_facility: Ivano-Frankivsk Regional Phthisiology-Pulmonology Center of Ivano-Frankivsk regional council

location_facility: Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UPECLIN - UNESP

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Unidad Medica para la Salud Integral (UMSI)

location_facility: Miskolci Semmelweis Ignác Health Centre and Educational Clinic Nonprofit Ltd.

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Azienda Ospedaliera Universitaria Senese, Policlinico "Le Scotte"

location_facility: Agaplesion Evangelisches Krankenhaus Mittelhessen

location_facility: Centro Regional para el estudio del Adulto Mayor, Servicio de Geriatria, Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Oaxaca Site Management Organization S.C. (OSMO)

location_facility: Longarts - Opleider Longziekten Zuyderland MC

location_facility: HSL-PUCRS Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul

location_facility: Municipal Institution of health care "Kharkiv City Clinical Hospital №13", Pulmonology Department №1

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Manchester University NHS Foundation Trust

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Nemocnice Na Bulovce, Klinika pneumologie

location_facility: Service de Néphrologie, Hôpital Bretonneau, CHRU de Tours

location_facility: Semmelweis University Clinic of Pulmonology

location_facility: Instituto Nacional de Enfermedades Respiratorias INER

location_facility: National Institute of Phthisiology and Pulmonology named after F. G. Yanovskyi NAMS of Ukraine, Clinical and Functional Department

location_facility: American University of beirut medical center

location_facility: A.O.U Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Centre Memoire Ressources Recherche, Hopital F. MITTERRAND

location_facility: Ospedale G.B.Morgagni L.Pierantoni - Azienda Unita Sanitaria Locale (AUSL) di Forli

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: Hospital Nacional Cayetano Heredia / Servicio de Inmunología y Reumatología

location_facility: Hospital Universitario Nuestra Senora de Valme

location_facility: Orszagos Koranyi Tbc es Pulmonologiai Intezet, IV. Tudobelosztaly

location_facility: Hospital das Clínicas da UFMG - Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - CPC HC/UFMG

location_facility: St. Lucas Clinical Research Center SA de CV

location_facility: Communal non-profit enterprise "City clinical hospital #16" of Dnipro Сit Сouncil

location_facility: Investigacion Biomedica Aplicada de Hidalgo

location_facility: Azienda Ospedaliera Citta' della Salute e delle Scienza di Torino

location_facility: Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: Papworth Hospital NHS Foundation Trust, Advanced Heart Failure Unit

location_facility: C.H.R.U. de Montpellier - Hôpital Lapeyronie

location_facility: Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz

location_facility: Hospital Clinico San Carlos-Madrid C/Martin Lagos s/n

location_facility: INCOR - Instituto do Coração Centro de Pesquisa Prof. Dr. Fulvio Pileggi Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP

location_facility: Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

location_facility: Research Institute Of Clinical Medicine Todua Clinic


title: Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Single Oral Administration of Elafibranor 120 mg in Renal Impaired Patients and Healthy Subjects With Normal Renal Function

summary: This study is being conducted in order to assess the need for dose adjustment for elafibranor in participants with renal impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in severe renal impaired participants (eGFR<15mL/mn/1.73m^2) versus healthy participants after a single oral administration of elafibranor 120 mg

status: Completed

study_completion_date_type: Actual

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Genfit

location_country: Romania France

location_facility: ARENSIA Exploratory Medicine Unit, Nephrology Hospital Dr. Carol Davilla

status_simplified: Completed


type: Registry Identifier

title: LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH CAR T CELLS

summary:
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.

Subjects who received at least one GM T cell infusion, will be asked to roll-over to this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Germany
Finland
France
Japan
Norway
Belgium
Spain
Canada
United Kingdom

location_facility: The Leeds Teaching Hospitals NHS Trust - St James's University Hospital

location_facility: University of California San Diego Moores Cancer Center

location_facility: Hematology and Oncology Associates of SC, LLC

location_facility: Franciscan St. Francis Health - Indiana Blood and Marrow Transplantation (IBMT)

location_facility: Columbia University Medical Center/New York-Presbyterian Hospital

location_facility: Norton Cancer Institute Louisville Oncology

location_facility: University of Pennsylvania Perelman Center for Advanced Medicine

location_facility: NYU Langone Laura and Isaac Perlmutter Cancer Center

location_facility: Helsinki University Central Hospital (HUCH)

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Institute for Pediatric Hematology - Oncology, Leon Berard Cancer Center

location_facility: Robert-Rössle-Klinik im HELIOS Klinikum Berlin-Buch Klinik für Hämatologie, Onkologie u. Tumorimmuno

location_facility: University of Rochester James P. Wilmot Cancer Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Medizinische Klinik II ZIM,Hamatologie Onkologie Uniklinik Frankfurt

location_facility: Massachusetts General Hospital / Dana-Farber Cancer Institute

location_facility: Weill Cornell Medicine / New York Presbyterian Hospital

location_facility: Institut Clinic de Nefrologia i Urologia - Hospital Clinic i Provincial de Barcelona

location_facility: H. Lee Moffitt Cancer Center and Research Institute University of South Florida

location_facility: Winship Cancer Institute of Emory University

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Oregon Health and Science University OHSU

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Karmanos Cancer Center Wayne State University

location_facility: Hematology Oncology and clinical immunology / Heinrich-Heine-University

location_facility: Froedtert Hospital BMT Medical College of Wisconsin

location_facility: Azienda Sanitaria Ospedaliera San Giovanni Battista Molinette

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Lombardi Cancer Center - Georgetown University Hospital

location_facility: Sidney Kimmel Comp Cancer Center at Johns Hopkins

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien

location_facility: Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM)

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: University of Maryland - Greenebaum Comprehensive Cancer Center

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center

location_facility: Erasmus Medical Center - Daniel den Hoed

location_facility: Hospital Universitari Germans Trias i Pujol ICO Badalona

location_facility: Dana-Farber/Mass General Brigham Cancer Care, Inc

location_facility: Universitario de Salamanca - Hospital Clinico

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Tokyo Women's Medical University Hospital

location_facility: Princess Maxima Center for Pediatric Oncology

location_facility: Universitatsklinikum Wurzburg Medizinische Klinik und Poliklinik II

location_facility: University of California, San Francisco- California

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi

intervention_type: Genetic


title: A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma

acronym: apact

summary: The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.

status: Active, not recruiting

ReferenceType: background

ReferenceCitation: Young R, Mainwaring P, Clingan P, Parnis FX, Asghari G, Beale P, Aly A, Botteman M, Romano A, Ferrara S, Margunato-Debay S, Harris M. nab-Paclitaxel plus gemcitabine in metastatic pancreatic adenocarcinoma: Australian subset analyses of the phase III MPACT trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e325-e331. doi: 10.1111/ajco.12999. Epub 2018 Jun 22.

ReferenceCitation: Reni M, Zanon S, Balzano G, Passoni P, Pircher C, Chiaravalli M, Fugazza C, Ceraulo D, Nicoletti R, Arcidiacono PG, Macchini M, Peretti U, Castoldi R, Doglioni C, Falconi M, Partelli S, Gianni L. A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma. Eur J Cancer. 2018 Oct;102:95-102. doi: 10.1016/j.ejca.2018.07.007. Epub 2018 Aug 24.

ReferenceCitation: Fernández A, Salgado M, García A, Buxò E, Vera R, Adeva J, Jiménez-Fonseca P, Quintero G, Llorca C, Cañabate M, López LJ, Muñoz A, Ramírez P, González P, López C, Reboredo M, Gallardo E, Sanchez-Cánovas M, Gallego J, Guillén C, Ruiz-Miravet N, Navarro-Pérez V, De la Cámara J, Alés-Díaz I, Pazo-Cid RA, Carmona-Bayonas A. Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study. BMC Cancer. 2018 Nov 29;18(1):1185. doi: 10.1186/s12885-018-5101-3.

ReferenceCitation: Sonbol MB, Ahn DH, Goldstein D, Okusaka T, Tabernero J, Macarulla T, Reni M, Li CP, O'Neil B, Van Cutsem E, Bekaii-Saab T. CanStem111P trial: a Phase III study of napabucasin plus nab-paclitaxel with gemcitabine. Future Oncol. 2019 Apr;15(12):1295-1302. doi: 10.2217/fon-2018-0903. Epub 2019 Feb 15.

ReferenceType: derived

ReferenceCitation: Reni M, Braverman J, Hendifar A, Li CP, Macarulla T, Oh DY, Riess H, Tempero M, Lu B, Marcus J, Joshi N, Botteman M, Dueck AC. Evaluation of Minimal Important Difference and Responder Definition in the EORTC QLQ-PAN26 Module for Assessing Health-Related Quality of Life in Patients with Surgically Resected Pancreatic Adenocarcinoma. Ann Surg Oncol. 2021 Nov;28(12):7545-7554. doi: 10.1245/s10434-021-09816-z. Epub 2021 Apr 3.

family: Reni

full_name: Michele Reni

given: Michele

sequence: first

family: Braverman

full_name: Julia Braverman

given: Julia

sequence: additional

family: Hendifar

full_name: Andrew Hendifar

given: Andrew

family: Li

full_name: Chung-Pin Li

given: Chung-Pin

family: Macarulla

full_name: Teresa Macarulla

given: Teresa

family: Oh

full_name: Do-Youn Oh

given: Do-Youn

family: Riess

full_name: Hanno Riess

given: Hanno

family: Tempero

full_name: Margaret Tempero

given: Margaret

family: Lu

full_name: Brian Lu

given: Brian

family: Marcus

full_name: James Marcus

given: James

family: Joshi

full_name: Namita Joshi

given: Namita

family: Botteman

full_name: Marc Botteman

given: Marc

family: Dueck

full_name: Amylou C. Dueck

given: Amylou C.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Surgical Oncology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_country:
Finland
Australia
Belgium
Denmark
Taiwan
France
Canada
Korea, Republic of
Hong Kong
Netherlands
Singapore
Hungary
Ireland
Portugal
United States
Germany
United Kingdom
Italy
Austria
Czechia
Spain

location_facility: Praxis Internistischer Onkologie und Hamatologie Frechen

location_facility: Centre Hospitalier de L'Universite de Montreal St-Luc

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Cincinnati Medical CenterDivsion of Hematology OncologyThe Barrett Center

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy

location_facility: MSKCC at Mercy Medical Center Mercy RockvilleCenter

location_facility: Instituto Catalan de Oncologia-Hospital Duran

location_facility: University of California, San Francisco Cutaneous Oncology and Melanoma Center

location_facility: Salzburger Landkliniken St. Johanns-Spital

location_facility: Memorial Sloan-Kettering Cancer Center - NYC

location_facility: Praxis Internistischer Onkologie und Hamatologie Koln

location_facility: Oregon Health and Science University OHSU

location_facility: University of Miami and Sylvester Cancer Center

location_facility: Karmanos Cancer Center Wayne State University

location_facility: MSKCC at Phelps Memorial Hospital Center. Phelps Sleepy Hollow

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: University of Wisconsin - Madison Cancer Center

location_facility: Praxis für Innere Medizin, Dr.Oettle Helmut

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Northshore University Healthsystem Research Institute

location_facility: University of Rochester Cancer Center, James P. Wilmot Cancer Center

location_facility: Memorial Sloan Kettering Cancer Center West Harrison

location_facility: Klinikum der Universitat Munchen-Grosshadern

location_facility: Rocky Mountain Cancer Centers, LLP [Denver-Midtown]

location_facility: Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Hopital Edouard Herriot - Hepato-gastroenterologie

location_facility: Pole Des Specialites Medicales, Hopital Purpan

location_facility: Center Hospitalier Universitaire d' Angers

location_facility: Prince of Wales Hospital the Chinese University of Hong Kong

location_facility: Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: Hospital Clinico Universitario De Santiago De Compostela

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: State University of New York Upstate Medical Center

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: Klinikum der Johannes Gutenberg Uniervsitaet ,Haematologie

location_facility: Fovarosi Szent Istvan es Szent Laszlo Korhaz es Rendelointezet

location_facility: Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center

location_facility: The Center for Cancer and Blood Disorders - Fort Worth


intervention_type: Biological

lead_sponsor: MedImmune LLC

primary_purpose: Prevention

location_country:
Austria
United States
Sweden
United Kingdom
Lebanon
Germany
France
Bulgaria
Poland
Israel
Hungary
Belgium
Russian Federation
Spain
Denmark
Canada
Czech Republic

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: University Multifunctional Hospital for Active Treatment

location_facility: Regional Dispensary for Pulmonary Diseases with Inpatient sector-Rousse

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Szpital Kliniczny Uniwersytetu Medycznego im. Karola Jonschera

location_facility: Samodzielny Publiczny Szpital Akademii Medycznej

location_facility: Schneider Children's Medical Center of Israel

location_facility: St. Petersburg City Children's Hospital #1

location_facility: Children's Hospital and Research Center at Oakland

location_facility: Meshalkin Research Institue of Blood circulation

location_facility: Ginekologiczno-Poloznicy Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 im. Tadeusza Sokolowskiego Pomorskiej AM w Szczecinie

location_facility: Research Cardiology Institute of Tomsk Scientific Center

location_facility: Children's and Women's Hospital of BC, Room #1R11

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Gyermeksziv Kozpont

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"

location_facility: Suny At Stony Brook University Medical Center

location_facility: Universitätsklinik für Kinder- und Jugendheilkunde

location_facility: University of California Davis Medical Center

location_facility: Szegedi Tudomanyegyetem AOK, Gyermekgyogyaszati Klinika

location_facility: Hospital Infantil Universitario Virgen del Rocío

location_facility: Saint Petersburg State Pediatric Medical Academy

location_facility: Washington University School of Medicine

location_facility: Multifunctional Hospital for Active Treatment - Pleven

location_facility: Dzieciecy Szpital Kliniczny im. Prof. Antoniego Gebal Poliklinika

location_facility: University Mulitiprofile Hospital for Active Treatment "St.Georgi"

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: James Whitcomb Riley Hospital for Children

location_facility: Specialized Hospital for Active Treatment of Cardio-vascular Diseases

location_facility: American University of Beirut Medical Center

location_facility: Ziekenhuisnetwerk Antwerpen - Koningin Paola Kinderziekenhuis

location_facility: Nemours Children's Clinic Biomedical Research Department

location_facility: Specialized Hospital for Active Treatment of Pediatric Diseases

location_facility: Veszprém Megyei Önkormányzat - Csolnoky Ferenc Kórház

location_facility: Tulane University Health Sciences Center

location_facility: Wojewodzki Szpital Dzieciecy W Bydgoszczy

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wojewodzki Szpital im. dr Jana Biziela w Bydgoszczy

title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children With Hemodynamically Significant Congenital Heart Disease

summary: The primary goal was to describe the safety of the investigational product when given monthly to prevent serious respiratory infection among children with significant heart disease.


title: Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus Cyclophosphamide, Doxorubicin and Vincristine (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinum-containing Line (ATLANTIS)

acronym: ATLANTIS

summary: Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line.

lead_sponsor: PharmaMar

location_country:
Italy
Austria
Brazil
Lebanon
Netherlands
Germany
Spain
France
Bulgaria
Czechia
Greece
Poland
Romania
Hungary
Argentina
Belgium
Portugal
United States
United Kingdom
Canada

location_facility: Complejo hospitalario regional virgen rocío

location_facility: St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare

location_facility: Mazowieckie Centrum Leczenia Chorób Pluc i Gruźlicy Oddzial III Chorób Pluc z Pododdzialem Onkologicznym

location_facility: Joliet Oncology-Hematology Associates, Ltd.

location_facility: Országos Korányi TBC és Pulmonológiai Intézet, 6. Pulmonológia és Bronchologia

location_facility: Anne Arundel Medical Center Oncology and Hematology

location_facility: Veszprém Megyei Tüdögyógyintézet, 3. Pulmonológiai Osztály

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. K.Marcinkowskiego w Poznaniu, Oddzial Chemioterapii

location_facility: CORI - Centro Oncológico Riojano Integral

location_facility: Instituto COl de Pesquisa, Educação e Gestão

location_facility: General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Internal Medicine-Oncology Clinic

location_facility: Center for Pneumology and Thoracic Surgery

location_facility: Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii Klinicznej, Oddzial Onkologii i Radioterapii

location_facility: Hospital Regional Universitario de Malaga

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Worcestershire Acute Hospitals NHS Trust

location_facility: Vitkovicka nemocnice, a.s., Plicni oddeleni

location_facility: General Hospital of Chest Diseases of Athens "Sotiria"

location_facility: Klinik Löwenstein gGmbH, Med. Klinik II Onkologie

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Coordenação de Pesquisa Clínica / Instituto Nacional de Câncer

location_facility: Centro Hospitalar do Porto, EPE - Hospital de Santo António

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Universitätsklinikum Ulm - Klinik für Innere Medizin II, Pneumologie

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte

location_facility: Corporació Sanitaria Parc Taulí-Hospital de Sabadell

location_facility: Miskolci Semmelweis Kórház és Egyetemi Oktatókórház, Pulmonológiai Osztály

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie; Oddzial Onkologii Klinicznej im. dr Ewy Pileckiej z pododdzialem

location_facility: Országos Korányi TBC és Pulmonológiai lntézet, 14. Pulmonológia

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Medical Oncology Associates PS (dba Summit Cancer Centers)

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Medizinische Universität Wien / AKH Wien, Universitätsklinik für Innere Medizin I, Abteilung für klinische Onkologie

location_facility: Johannes Wesling Klinikum Minden, Klinik für Hämatologie, Onkologie und Palliativmedizin

location_facility: Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Dcpartamentul Oncologie Medicala

location_facility: SC Centrul de Oncologie Sf. Nectarie SRL, Departament Oncologie Medícala

location_facility: Hôpital Nord - Service Oncologie Multidisciplinaire et Innovations Thérapeutiques

location_facility: Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

location_facility: lnstituto de Ensino e Pesquisa Säo Lucas - IEP Säo Lucas

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Departament Oncologie Medicala

location_facility: Universitätsklinik für Innere Medizin III der PMU

location_facility: ASST della Valtellina e dell' Alto Lario P.O. Di Sondrio

location_facility: Centro para la Atención Integral del Paciente Oncológico (CAIPO)

location_facility: Hospital Universitario Clínico San Carlos

location_facility: Centre Hospitalier Lyon Sud - Service de Pneumologie

location_facility: Markusovszky Egyetemi Oktatókórház, Pulmonológiai Osztály

location_facility: Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

location_facility: University of Munich LMU, Dpt. of Medicine V

location_facility: Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Sectia Oncologic Medicala

location_facility: Krajska zdravotni a.s. Masarykova nemocnice o.z.

location_facility: R.S. Mc Laughlin Durham Regional Cancer Centre, Lakeridge Health

location_facility: Hospital General Universitario de Valencia

location_facility: Multiprofile Hospital for Active Treatment of Women Health - "Nadezhda", Sofia; Clinic of Medical Oncology

location_facility: Froedtert Hospital & the Medical College of Wisconsin

location_facility: Uniklinikum Mannheim, TTZ, Medizinische Fakultät Mannheim

location_facility: Centro Clínico Champalimaud - Fundação Champalimaud

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"

location_facility: Vivantes Klinikum am Urban, Hämatologie und Onkologie

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház, I. Pulmonológiai Osztály

location_facility: University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski", Sofia

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Szent Borbála Kórház, Pulmonológiai osztály

location_facility: Hospital Universitari Germans Trias i Pujol ICO

location_facility: Hammoud Hospital University Medical Center

location_facility: AOU Maggiore della Carità - SC Oncologia

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Katholisches Klinikum Koblenz-Montabaur, Marienhof Koblenz

location_facility: General Hospital of Thessaloniki "G. Papanikolaou", Pulmonary Clinic, Aristotle University of Thessaloniki

location_facility: Klinikum Bogenhausen, Städt. Klinikum München GmbH, Klinik für Pneumologie und Pneumologische Onkologie

location_facility: Boca Raton Regional Hospital Lynn Cancer Institute

location_facility: The Center for Cancer and Blood Disorders

location_facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris", Sectia Oncologie Medicala

location_facility: Bristol Cancer Institute, UHB NHS Foundation Trust

location_facility: IRCCS CROB (Istituto di Ricovero e Cura a Carattere Scientifico)

location_facility: Centre Hospitalier Universitaire Notre Dame de Secours

location_facility: East Jefferson Hematology-Oncology Metairie Physicians Services, Inc

location_facility: Uniklinik Freiburg, Hämatologie, Onkologie & Stammzellransplantation

location_facility: Städtisches Krankenhaus München Neuperlach

location_facility: Klinikum Nürnberg Nord - Pneumologische Onkologie

location_facility: lrmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Associates in Hematology and Oncology, P.C.

location_facility: MultiCare Institute for Research & Innovation

location_facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment. EOOD, Sofia; Clinic of Medical Oncology

location_facility: Southlake Regional Health Centre - Stronach Regional Cancer Centre

location_facility: Instituto Médico Especializado Alexander Fleming

location_facility: Fundação PlO XII - Hospital de Câncer de Barretos

location_facility: University General Hospital of Heraklion - General Hospital "Venizeleio"

location_facility: Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Presidio G. Rodolico

location_facility: Centro Hospitalar Lisboa Norte, EPE- Hospital Pulido Valente

location_facility: Centre intégré de santé et de services sociaux de la Montérégie Centre

location_facility: Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital

location_facility: The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Innovative Clinical Research Institute (ICRI)


lead_sponsor: University Hospital Muenster

location_country:
Italy
Germany
United Kingdom
France

acronym: Doxo

location_facility: MD Nicolas Andre, National Study Manager France

location_facility: Prof. Maurizio D'Incalci, National Study Manager Italy

location_facility: Royal Victoria Infirmary, Sir James Spence Institute of Child Health

location_facility: Great Ormond Street Hospital for Children

location_facility: Prof. Alan Boddy, National Study Manager UK

title: Phase II Pharmacokinetic Study to Assess the Age-dependency in the Clearance of Doxorubicin in Paediatric Patients With Solid Tumours and Leukaemia

summary: Analyze pharmacokinetics of doxorubicin in children with cancer. Furthermore investigate the predictive role of troponin and natriuretic peptides for anthracycline-induced cardiotoxicity .

lead_sponsor_type: academique


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

summary: This is a Phase 3 trial to evaluate the efficacy and safety of 30 mg/kg intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in subjects with Idiopathic Pulmonary Fibrosis

ipd_sharing: Undecided

location_country:
Italy
Chile
Peru
Hong Kong
Lebanon
Netherlands
Germany
Spain
France
Czechia
Hungary
Argentina
Australia
Russian Federation
China
United States
Korea, Republic of
Taiwan

location_facility: Centro de Investigacion Metabolica 'CINME'

location_facility: FSBEI HE First Pavlov Medical University

location_facility: Union Hospital，Tongji Medical College of Huazhong University of Science and Technology

location_facility: Affiliated Hospital of Inner Mongolia Medical University

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: City Clinical Hospital #1 n.a. A.N. Kabanov

location_facility: Euromedservice, Clinical and Diagnostic Center

location_facility: Banner University Medical Center - Phoenix

location_facility: Agaplesion Evangelisches Krankenhaus Mittelhessen

location_facility: Fundacion Respirar - Centro Médico Dra. De Salvo

location_facility: The Catholic University of Korea, Bucheon St. Mary's Hospital

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: Houston Pulmonary Sleep, Allergy and Asthma Associates

location_facility: Pulmonary Disease Specialist, PA d/b/a, PDS Research

location_facility: Shanghai Pulmonary Hospital of Tongji University

location_facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: The second hospital of Dalian medical university

location_facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Centro Platense en Investigaciones Respiratorias

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: University of Florida Health, Jacksonville

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Baylor Scott and White Research Institute

location_facility: Kazan State Medical University based on Republican Clinical Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: University of Alabama at Birmingham Hospital

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Centro de Investigacion Clinica V Region CINVEC

location_facility: Second Affiliated Hospital of Anhui Medical University

location_facility: Centro de Investigación Clínica Aplicada - Hospital Regional Español Bahía Blanca

location_facility: People's Hospital of Inner Mongolia Autonomous Region

location_facility: General Hospital of Ningxia Medical University

location_facility: Hospital Nacional Cayetano Heredia / Servicio de Inmunología y Reumatología

location_facility: Taipei Medical University - Shuang-Ho Hospital, Ministry of Health and Welfare

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: The Second Xiangya Hospital of Central South University

location_facility: The First Hospital of China Medical University

location_facility: The Second Affiliated Hospital of Xi'an Jiaotong University

location_facility: University of Florida Pulmonary, Critical Care & Sleep Medicine Division

location_facility: Consultorios Medicos. Organización del Buen Ayre. SRL

location_facility: BeiJing Chao-Yang Hospital,Capital medical university

location_facility: Centro Medico de Enfermedades Respiratorias

location_facility: C.H.R.U. de Montpellier - Hôpital Lapeyronie

location_facility: Investigaciones en Patologias Respiratorias

location_facility: Tennessee Comprehensive Lung and Sleep Center

location_facility: Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

location_facility: University of Texas Southwestern Medical Center

location_facility: General Hospital of Tianjin Medical University


title: PRessure suppOrT vEntilation + Sigh in aCuTe hypoxemIc respiratOry Failure patieNts (PROTECTION): a Pilot Randomized Controlled Trial

acronym: PROTECTION

summary:
Mortality of intubated acute hypoxemic respiratory failure (AHRF) and acute respiratory distress syndrome (ARDS) patients remains considerably high (around 40%) (Bellani 2016). Early implementation of a specific mechanical ventilation mode that enhances lung protection in patients with mild to moderate AHRF and ARDS on spontaneous breathing may have a tremendous impact on clinical practice.

Previous studies showed that the addition of cyclic short recruitment maneuvers (Sigh) to assisted mechanical ventilation: improves oxygenation without increasing ventilation pressures and FiO2; decreases the tidal volumes by decreasing the patient's inspiratory drive; increases the EELV by regional alveolar recruitment; decreases regional heterogeneity of lung parenchyma; decreases patients' inspiratory efforts limiting transpulmonary pressure; improves regional compliances. Thus, physiologic studies generated the hypothesis that addition of Sigh to pressure support ventilation (PSV, the most common assisted mechanical ventilation mode) might decrease ventilation pressures and FiO2, and limit regional lung strain and stress through various synergic mechanisms potentially yielding decreased risk of VILI, faster weaning and improved clinical outcomes.

The investigators conceived a pilot RCT to verify clinical feasibility of the addition of Sigh to PSV in comparison to standard PSV.

The investigators will enrol 258 intubated spontaneously breathing patients with mild to moderate AHRF and ARDS admitted to the ICU.

Patients will be randomized through an online automatic centralized and computerized system to the following study groups (1:1 ratio):

PSV group: will be treated by protective PSV settings until day 28 or death or performance of spontaneous breathing trial (SBT);
PSV+Sigh group: will be treated by protective PSV settings with the addition of Sigh until day 28 or death or performance of spontaneous breathing trial (SBT).

Indications on ventilation settings, weaning, spontaneous breathing trial and rescue treatment will be specified.

ReferenceCitation: Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.

name: School of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy2Department of Emergency and Intensive Care, San Gerardo Hospital, Monza, Italy

family: Bellani

full_name: Giacomo Bellani

given: Giacomo

name: Departments of Anesthesia and Critical Care Medicine, Keenan Research Centre for Biomedical Science, St Michael’s Hospital4Departments of Anesthesia, Physiology and Interdepartmental division of Critical Care Medicine, University of Toronto, Canada

family: Laffey

full_name: John G. Laffey

given: John G.

name: AP-HP, Hôpital Tenon, Unité de Réanimation médico-chirurgicale, Pôle Thorax Voies aériennes, Groupe hospitalier des Hôpitaux Universitaires de l’Est Parisien, Paris, France6UMR 1153, Inserm, Sorbonne Paris Cité, ECSTRA Team, Université Paris Diderot, Pari

family: Pham

full_name: Tài Pham

given: Tài

name: Department of Medicine, University Health Network and Mount Sinai Hospital9Interdepartmental Division of Critical Care Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada

family: Fan

full_name: Eddy Fan

given: Eddy

name: Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, Canada11Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada

family: Brochard

full_name: Laurent Brochard

given: Laurent

name: Hospital Universitario de Getafe, CIBER de Enfermedades Respiratorias, Madrid, Spain

family: Esteban

full_name: Andres Esteban

given: Andres

name: Istituto di Anestesia e Rianimazione, Università degli Studi di Milano, Ospedale Maggiore, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy

family: Gattinoni

full_name: Luciano Gattinoni

given: Luciano

name: Intensive Care Unit, Canberra Hospital, and Australian National University, Canberra, Australia

family: van Haren

full_name: Frank van Haren

given: Frank

name: Section of Anesthesiology and Intensive Care, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden

family: Larsson

full_name: Anders Larsson

given: Anders

name: Centre for Experimental Medicine, Queen's University of Belfast, Belfast, Northern Ireland17Wellcome-Wolfson Institute for Experimental Medicine, Belfast, Northern Ireland18Regional Intensive Care Unit, Royal Victoria Hospital, Grosvenor Road, Belfast, No

family: McAuley

full_name: Daniel F. McAuley

given: Daniel F.

name: SAPIENZA Università di ROMA, Dipartimento di Anestesia e Rianimazione, Policlinico Umberto I, Viale del Policlinico 155, 00161 Roma, Italy

family: Ranieri

full_name: Marco Ranieri

given: Marco

name: Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada21Program in Trauma, Emergency and Critical Care, Sunnybrook Health Sciences Center, Toronto, Canada

family: Rubenfeld

full_name: Gordon Rubenfeld

given: Gordon

name: Division of Pulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston

family: Thompson

full_name: B. Taylor Thompson

given: B. Taylor

name: Department of Anesthesiology and Intensive Care Medicine, University of Leipzig, Liebigstr. 20, D-04103 Leipzig, Germany

family: Wrigge

full_name: Hermann Wrigge

given: Hermann

name: Keenan Research Center at the Li Ka Shing Knowledge Institute of St Michael’s Hospital, the Interdepartmental Division of Critical Care Medicine, and the Department of Medicine, University of Toronto, Toronto, Canada

family: Slutsky

full_name: Arthur S. Slutsky

given: Arthur S.

family: Pesenti

full_name: Antonio Pesenti

given: Antonio

name: for the LUNG SAFE Investigators and the ESICM Trials Group

journal_name: JAMA

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: Queen's University Belfast - Research Portal

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Matthay MA, Ware LB, Zimmerman GA. The acute respiratory distress syndrome. J Clin Invest. 2012 Aug;122(8):2731-40. doi: 10.1172/JCI60331. Epub 2012 Aug 1. Review.

ReferenceCitation: Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2014 Mar 6;370(10):980. doi: 10.1056/NEJMc1400293.

ReferenceCitation: Mauri T, Foti G, Zanella A, Bombino M, Confalonieri A, Patroniti N, Bellani G, Pesenti A. Long-term extracorporeal membrane oxygenation with minimal ventilatory support: a new paradigm for severe ARDS? Minerva Anestesiol. 2012 Mar;78(3):385-9.

ReferenceCitation: Ranieri VM, Suter PM, Tortorella C, De Tullio R, Dayer JM, Brienza A, Bruno F, Slutsky AS. Effect of mechanical ventilation on inflammatory mediators in patients with acute respiratory distress syndrome: a randomized controlled trial. JAMA. 1999 Jul 7;282(1):54-61.

ReferenceCitation: Hussain SN, Cornachione AS, Guichon C, Al Khunaizi A, Leite Fde S, Petrof BJ, Mofarrahi M, Moroz N, de Varennes B, Goldberg P, Rassier DE. Prolonged controlled mechanical ventilation in humans triggers myofibrillar contractile dysfunction and myofilament protein loss in the diaphragm. Thorax. 2016 May;71(5):436-45. doi: 10.1136/thoraxjnl-2015-207559. Epub 2016 Mar 31.

ReferenceCitation: Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guérin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.

title: Neuromuscular Blockers in Early Acute Respiratory Distress Syndrome

ReferenceCitation: Guérin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

title: Prone Positioning in Severe Acute Respiratory Distress Syndrome

ReferenceCitation: Kallet RH, Matthay MA. Hyperoxic acute lung injury. Respir Care. 2013 Jan;58(1):123-41. doi: 10.4187/respcare.01963. Review.

ReferenceCitation: Bellani G, Guerra L, Musch G, Zanella A, Patroniti N, Mauri T, Messa C, Pesenti A. Lung regional metabolic activity and gas volume changes induced by tidal ventilation in patients with acute lung injury. Am J Respir Crit Care Med. 2011 May 1;183(9):1193-9. doi: 10.1164/rccm.201008-1318OC. Epub 2011 Jan 21.

ReferenceCitation: Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. The comparison of spontaneous breathing and muscle paralysis in two different severities of experimental lung injury. Crit Care Med. 2013 Feb;41(2):536-45. doi: 10.1097/CCM.0b013e3182711972.

ReferenceCitation: Foti G, Cereda M, Sparacino ME, De Marchi L, Villa F, Pesenti A. Effects of periodic lung recruitment maneuvers on gas exchange and respiratory mechanics in mechanically ventilated acute respiratory distress syndrome (ARDS) patients. Intensive Care Med. 2000 May;26(5):501-7.

ReferenceCitation: Patroniti N, Foti G, Cortinovis B, Maggioni E, Bigatello LM, Cereda M, Pesenti A. Sigh improves gas exchange and lung volume in patients with acute respiratory distress syndrome undergoing pressure support ventilation. Anesthesiology. 2002 Apr;96(4):788-94.

ReferenceCitation: Nacoti M, Spagnolli E, Bonanomi E, Barbanti C, Cereda M, Fumagalli R. Sigh improves gas exchange and respiratory mechanics in children undergoing pressure support after major surgery. Minerva Anestesiol. 2012 Aug;78(8):920-9. Epub 2012 Apr 27.

ReferenceCitation: Mauri T, Eronia N, Abbruzzese C, Marcolin R, Coppadoro A, Spadaro S, Patroniti N, Bellani G, Pesenti A. Effects of Sigh on Regional Lung Strain and Ventilation Heterogeneity in Acute Respiratory Failure Patients Undergoing Assisted Mechanical Ventilation. Crit Care Med. 2015 Sep;43(9):1823-31. doi: 10.1097/CCM.0000000000001083.

ReferenceCitation: Tabuchi A, Nickles HT, Kim M, Semple JW, Koch E, Brochard L, Slutsky AS, Pries AR, Kuebler WM. Acute Lung Injury Causes Asynchronous Alveolar Ventilation That Can Be Corrected by Individual Sighs. Am J Respir Crit Care Med. 2016 Feb 15;193(4):396-406. doi: 10.1164/rccm.201505-0901OC.

ReferenceCitation: Güldner A, Braune A, Carvalho N, Beda A, Zeidler S, Wiedemann B, Wunderlich G, Andreeff M, Uhlig C, Spieth PM, Koch T, Pelosi P, Kotzerke J, de Abreu MG. Higher levels of spontaneous breathing induce lung recruitment and reduce global stress/strain in experimental lung injury. Anesthesiology. 2014 Mar;120(3):673-82. doi: 10.1097/ALN.0000000000000124.

ReferenceCitation: Moraes L, Santos CL, Santos RS, Cruz FF, Saddy F, Morales MM, Capelozzi VL, Silva PL, de Abreu MG, Garcia CS, Pelosi P, Rocco PR. Effects of sigh during pressure control and pressure support ventilation in pulmonary and extrapulmonary mild acute lung injury. Crit Care. 2014 Aug 12;18(4):474. doi: 10.1186/s13054-014-0474-4.

ReferenceCitation: Goligher EC, Kavanagh BP, Rubenfeld GD, Ferguson ND. Physiologic Responsiveness Should Guide Entry into Randomized Controlled Trials. Am J Respir Crit Care Med. 2015 Dec 15;192(12):1416-9. doi: 10.1164/rccm.201410-1832CP. Review.

ReferenceCitation: Riker RR, Fugate JE; Participants in the International Multi-disciplinary Consensus Conference on Multimodality Monitoring. Clinical monitoring scales in acute brain injury: assessment of coma, pain, agitation, and delirium. Neurocrit Care. 2014 Dec;21 Suppl 2:S27-37. doi: 10.1007/s12028-014-0025-5. Review.

ReferenceCitation: Goligher EC, Kavanagh BP, Rubenfeld GD, Adhikari NK, Pinto R, Fan E, Brochard LJ, Granton JT, Mercat A, Marie Richard JC, Chretien JM, Jones GL, Cook DJ, Stewart TE, Slutsky AS, Meade MO, Ferguson ND. Oxygenation response to positive end-expiratory pressure predicts mortality in acute respiratory distress syndrome. A secondary analysis of the LOVS and ExPress trials. Am J Respir Crit Care Med. 2014 Jul 1;190(1):70-6. doi: 10.1164/rccm.201404-0688OC.

ReferenceCitation: Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.

ReferenceCitation: Xirouchaki N, Kondili E, Vaporidi K, Xirouchakis G, Klimathianaki M, Gavriilidis G, Alexandopoulou E, Plataki M, Alexopoulou C, Georgopoulos D. Proportional assist ventilation with load-adjustable gain factors in critically ill patients: comparison with pressure support. Intensive Care Med. 2008 Nov;34(11):2026-34. doi: 10.1007/s00134-008-1209-2. Epub 2008 Jul 8.

ReferenceCitation: Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D; CESAR trial collaboration. Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1351-63. doi: 10.1016/S0140-6736(09)61069-2. Epub 2009 Sep 15. Erratum in: Lancet. 2009 Oct 17;374(9698):1330.

ReferenceCitation: Mauri T, Foti G, Fornari C, Grasselli G, Pinciroli R, Lovisari F, Tubiolo D, Volta CA, Spadaro S, Rona R, Rondelli E, Navalesi P, Garofalo E, Knafelj R, Gorjup V, Colombo R, Cortegiani A, Zhou JX, D'Andrea R, Calamai I, Vidal González Á, Roca O, Grieco DL, Jovaisa T, Bampalis D, Becher T, Battaglini D, Ge H, Luz M, Constantin JM, Ranieri M, Guerin C, Mancebo J, Pelosi P, Fumagalli R, Brochard L, Pesenti A; PROTECTION Trial Collaborators. Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS: The PROTECTION Pilot Randomized Clinical Trial. Chest. 2021 Apr;159(4):1426-1436. doi: 10.1016/j.chest.2020.10.079. Epub 2020 Nov 13.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

ReferenceCitation: Mauri T, Foti G, Fornari C, Constantin JM, Guerin C, Pelosi P, Ranieri M, Conti S, Tubiolo D, Rondelli E, Lovisari F, Fossali T, Spadaro S, Grieco DL, Navalesi P, Calamai I, Becher T, Roca O, Wang YM, Knafelj R, Cortegiani A, Mancebo J, Brochard L, Pesenti A; Protection Study Group. Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial. Trials. 2018 Aug 29;19(1):460. doi: 10.1186/s13063-018-2828-8.

repository_institution: Università degli Studi di Milano - Institutional Research Information System

lead_sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_country:
Italy
Spain
France
Greece
China
Germany
United Kingdom

location_facility: UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Kiel

location_facility: Barking, Havering and Redbridge Hospital


title: APEX-AMI - Pexelizumab in Conjunction With Angioplasty

summary: In the setting of reperfusion therapy in an acute myocardial infarction using primary percutaneous intervention (PCI), the body's own inflammatory system involving the complement cascade may be harmful. This study will test the safety and efficacy of a novel complement inhibitor, pexelizumab to reduce mortality at 30 days.

ReferenceCitation: Bagai A, Armstrong PW, Stebbins A, Mahaffey KW, Hochman JS, Weaver WD, Patel MR, Granger CB, Lopes RD. Prognostic implications of left ventricular end-diastolic pressure during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: Findings from the Assessment of Pexelizumab in Acute Myocardial Infarction study. Am Heart J. 2013 Nov;166(5):913-9. doi: 10.1016/j.ahj.2013.08.006. Epub 2013 Sep 24.

family: Bagai

full_name: Akshay Bagai

given: Akshay

family: Armstrong

full_name: Paul W. Armstrong

given: Paul W.

family: Stebbins

full_name: Amanda Stebbins

given: Amanda

family: Mahaffey

full_name: Kenneth W. Mahaffey

given: Kenneth W.

family: Hochman

full_name: Judith S. Hochman

given: Judith S.

family: Weaver

full_name: W. Douglas Weaver

given: W. Douglas

family: Patel

full_name: Manesh R. Patel

given: Manesh R.

family: Granger

full_name: Christopher B. Granger

given: Christopher B.

family: Lopes

full_name: Renato D. Lopes

given: Renato D.

journal_name: American Heart Journal

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Guptill JT, Mehta RH, Armstrong PW, Horton J, Laskowitz D, James S, Granger CB, Lopes RD. Stroke after primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction: timing, characteristics, and clinical outcomes. Circ Cardiovasc Interv. 2013 Apr;6(2):176-83. doi: 10.1161/CIRCINTERVENTIONS.112.000159. Epub 2013 Apr 2.

name: From the Duke Clinical Research Institute, Durham, NC (J.T.G., R.H.M., J.H., D.L., C.B.G., R.D.L.); University of Alberta, Edmonton, Alberta, Canada (P.W.A.); and Uppsala Clinical Research Center, Uppsala, Sweden (S.J.).

family: Guptill

full_name: Jeffrey T. Guptill

given: Jeffrey T.

family: Mehta

full_name: Rajendra H. Mehta

given: Rajendra H.

family: Horton

full_name: John Horton

given: John

family: Laskowitz

full_name: Daniel Laskowitz

given: Daniel

family: James

full_name: Stefan James

given: Stefan

oa_host_type: publisher

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Stroke After Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction

ReferenceCitation: Westerhout CM, Pieper KS, James SK, Mahaffey KW, de Werf FV, Califf RM, Granger CB, Armstrong PW. Dynamic modeling of 90-day mortality in ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention. Am Heart J. 2013 Mar;165(3):354-62.e2. doi: 10.1016/j.ahj.2012.12.001. Epub 2013 Jan 15.

family: Westerhout

full_name: Cynthia M. Westerhout

ReferenceCitation: Patel MR, Westerhout CM, Granger CB, Brener SJ, Fu Y, Siha H, Kim RJ, Armstrong PW. Aborted myocardial infarction after primary percutaneous coronary intervention: magnetic resonance imaging insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2013 Feb;165(2):226-33. doi: 10.1016/j.ahj.2012.10.028. Epub 2012 Nov 24.

title: Aborted myocardial infarction after primary percutaneous coronary intervention: Magnetic resonance imaging insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial

ReferenceCitation: Truffa AA, Granger CB, White KR, Newby LK, Mehta RH, Hochman JS, Patel MR, Pieper KS, Al-Khalidi HR, Armstrong PW, Lopes RD. Serious infection after acute myocardial infarction: incidence, clinical features, and outcomes. JACC Cardiovasc Interv. 2012 Jul;5(7):769-76. doi: 10.1016/j.jcin.2012.03.018.

title: Serious Infection After Acute Myocardial Infarction

ReferenceCitation: Martel C, Granger CB, Ghitescu M, Stebbins A, Fortier A, Armstrong PW, Bonnefoy A, Theroux P. Pexelizumab fails to inhibit assembly of the terminal complement complex in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Insight from a substudy of the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2012 Jul;164(1):43-51. doi: 10.1016/j.ahj.2012.04.007. Epub 2012 Jun 15.

ReferenceCitation: van Diepen S, Widimsky P, Lopes RD, White KR, Weaver WD, Van de Werf F, Ardissino D, van't Hof AW, Armstrong PW, Granger CB. Transfer times and outcomes in patients with ST-segment-elevation myocardial infarction undergoing interhospital transfer for primary percutaneous coronary intervention: APEX-AMI insights. Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):437-44. doi: 10.1161/CIRCOUTCOMES.112.965160. Epub 2012 May 15.

name: From the Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.V.D., R.D.L., K.R.W., C.B.G.); Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada (S.V.D., P.W.A.); Faculty of Medicine, Charles University Prague, Czech Republic (P.W.); Henry Ford Hospital, Detroit, MI (W.D.W.); University Hospitals Leuven, Leuven, Belgium (F.V.D.W.); Universitaria Di Parma, Parma, Italy (D.A.); Isala Klinieken, Zwolle, The Netherlands (A.W.J.H.).

journal_name: Circulation: Cardiovascular Quality and Outcomes

title: Transfer Times and Outcomes in Patients With ST-Segment–Elevation Myocardial Infarction Undergoing Interhospital Transfer for Primary Percutaneous Coronary Intervention

ReferenceCitation: Hudson MP, Armstrong PW, O'Neil WW, Stebbins AL, Weaver WD, Widimsky P, Aylward PE, Ruzyllo W, Holmes D, Mahaffey KW, Granger CB. Mortality implications of primary percutaneous coronary intervention treatment delays: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction trial. Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):183-92. doi: 10.1161/CIRCOUTCOMES.110.945311. Epub 2011 Feb 8.

name: From the Henry Ford Heart & Vascular Institute (M.H., D.W.), Detroit, MI; University of Alberta (P.W.A.), Edmonton, Alberta, Canada; University of Miami–Miller School of Medicine (W.O.), Miami, FL; Duke Clinical Research Institute (A.S., K.M., C.B.), Durham, NC; University Hospital Vinohrady (P.W.), Prague, Czech Republic; Flinders Cardiovascular Center (P.E.A.), Adelaide, Australia; Institute of Cardiology (W.R.), Warsaw, Poland; and the Mayo Clinic and Foundation (D.H.); Rochester, MN.

title: Mortality Implications of Primary Percutaneous Coronary Intervention Treatment Delays: Insights From the Assessment of Pexelizumab in Acute Myocardial Infarction Trial

ReferenceCitation: Huber K, Holmes DR Jr, van 't Hof AW, Montalescot G, Aylward PE, Betriu GA, Widimsky P, Westerhout CM, Granger CB, Armstrong PW. Use of glycoprotein IIb/IIIa inhibitors in primary percutaneous coronary intervention: insights from the APEX-AMI trial. Eur Heart J. 2010 Jul;31(14):1708-16. doi: 10.1093/eurheartj/ehq143. Epub 2010 May 25.

ReferenceCitation: Alhadramy O, Westerhout CM, Brener SJ, Granger CB, Armstrong PW; APEX AMI Investigators. Is visual interpretation of coronary epicardial flow reliable in patients with ST-elevation myocardial infarction undergoing primary angioplasty? Insights from the angiographic substudy of the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2010 May;159(5):899-904. doi: 10.1016/j.ahj.2010.02.028.

ReferenceCitation: Patel MR, Worthley SG, Stebbins A, Dill T, Rademakers FE, Valeti US, Barsness GW, Van de Werf F, Hamm CW, Armstrong PW, Granger CB, Kim RJ. Pexelizumab and infarct size in patients with acute myocardial infarction undergoing primary percutaneous coronary Intervention: a delayed enhancement cardiac magnetic resonance substudy from the APEX-AMI trial. JACC Cardiovasc Imaging. 2010 Jan;3(1):52-60. doi: 10.1016/j.jcmg.2009.09.014. Epub 2010 Jan 12. Erratum in: JACC Cardiovasc Imaging. 2010 Jul;3(7):796. Velleti, Uma S [corrected to Valeti, Uma S].

title: Pexelizumab and Infarct Size in Patients With Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

ReferenceCitation: Trendelenburg M, Theroux P, Stebbins A, Granger C, Armstrong P, Pfisterer M. Influence of functional deficiency of complement mannose-binding lectin on outcome of patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Eur Heart J. 2010 May;31(10):1181-7. doi: 10.1093/eurheartj/ehp597. Epub 2010 Jan 19.

evidence: oa repository (via OAI-PMH title and first author match)

ReferenceCitation: Brener SJ, Westerhout CM, Fu Y, Todaro TG, Moliterno DJ, Wagner GS, Granger CB, Armstrong PW; APEX-AMI Investigators. Contribution of angiographic and electrocardiographic parameters of reperfusion to prediction of mortality and morbidity after acute ST-elevation myocardial infarction: Insights from the Assessment of Pexelizumab in Acute Myocardial Infarction trial. Am Heart J. 2009 Nov;158(5):755-60. doi: 10.1016/j.ahj.2009.09.009. Epub 2009 Oct 3.

ReferenceCitation: Armstrong PW, Fu Y, Westerhout CM, Hudson MP, Mahaffey KW, White HD, Todaro TG, Adams PX, Aylward PE, Granger CB. Baseline Q-wave surpasses time from symptom onset as a prognostic marker in ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention. J Am Coll Cardiol. 2009 Apr 28;53(17):1503-9. doi: 10.1016/j.jacc.2009.01.046.

journal_name: Journal of the American College of Cardiology

title: Baseline Q-Wave Surpasses Time From Symptom Onset as a Prognostic Marker in ST-Segment Elevation Myocardial Infarction Patients Treated With Primary Percutaneous Coronary Intervention

ReferenceCitation: Buller CE, Fu Y, Mahaffey KW, Todaro TG, Adams P, Westerhout CM, White HD, van 't Hof AW, Van de Werf FJ, Wagner GS, Granger CB, Armstrong PW. ST-segment recovery and outcome after primary percutaneous coronary intervention for ST-elevation myocardial infarction: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Circulation. 2008 Sep 23;118(13):1335-46. doi: 10.1161/CIRCULATIONAHA.108.767772. Epub 2008 Sep 8.

name: From Vancouver General Hospital (C.E.B.), University of British Columbia, Vancouver, British Columbia, Canada; University of Alberta (Y.F., C.M.W., P.W.A.), Edmonton, Alberta, Canada; Duke Clinical Research Institute (K.W.M., G.S.W., C.B.G.), Durham, NC; Procter & Gamble (T.G.T.), Cincinnati, Ohio; Alexion Pharmaceuticals (P.A.), Cheshire, Conn; Green Lane Cardiovascular Research Unit (H.D.W.), Auckland, New Zealand; Isala Klinieken (A.W.J.v.H.), Zwolle, Netherlands; and University Hospital...

title: ST-Segment Recovery and Outcome After Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction

ReferenceCitation: APEX AMI Investigators, Armstrong PW, Granger CB, Adams PX, Hamm C, Holmes D Jr, O'Neill WW, Todaro TG, Vahanian A, Van de Werf F. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial. JAMA. 2007 Jan 3;297(1):43-51.

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Spain
Germany
France
Poland
Australia
Belgium
New Zealand
Portugal
Denmark
Canada
Czech Republic

location_facility: University of Oklahoma Health Sciences Center

location_facility: A.O. SS. Antonio e Biagio e Cesare Arrigo

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Kardiologicke odd., Nemocnice Na Homoice

location_facility: A.O. della Regione Lombardia Presidio Ospedaliero Sant'Anna

location_facility: Hospital Garcia de Orta - Servico de Cardiologia

location_facility: Hospital Sao Joao - Servico de Cardiologia

location_facility: Saint John Regional Hospital - New Brunswick Heart Centre

location_facility: II. Interni klinika, Vseobecna fakultni nemocnice

location_facility: Kardiologicke oddeleni, Masarykova nemocnice

location_facility: Universitatsklinik der Ruhr-Universitat Bochum

location_facility: MultiCare Medical Center (Tacoma General Hospital)

location_facility: Universitiy of Virginia Health Science Center

location_facility: I. interni kardioangiologicka klinika, Fakultni nemocnice u Sv. Anny

location_facility: Ciutat Sanitaria i Universitaria de Bellvitge

location_facility: Kardiologicke odd., Krajska neocnice Liberec

location_facility: Interni kardiologicka klinika, Fakultni nemocnice Brno

location_facility: I. Interni klinika, Fakultni nemocnice Plzen

location_facility: Kardio-Troll sro and Krajska nemocnice Pardubice

location_facility: University of Missouri Health Sciences Center

location_facility: South Texas Veterans Health Care System Audie L. Murphy Division

location_facility: Sunnybrook & Women's Health Sciences Centre

location_facility: Health First Holmes Regional Medical Center

location_facility: I. Interni klinika, Fakultni nemocnice Hradec

location_facility: Hospital of the University of Pennsylvania

location_facility: Centre Hospitale de'Universite de Montreal (Pav Notre-Dame)_

location_facility: Montreal Heart Institute/Research Centre

location_facility: Hopital d'adultes de Brabois (CHU de Nancy)

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Hospital General Universitario de Alicante

location_facility: SPZOZ Dolnoslaski Szpital Specjalistyczny

location_facility: Kardiologicke odd. Nemocnice Ceske Budejovice as

location_facility: Azienda Ospedaliera di Parma - Ospedale Maggiore

location_facility: Kardiocentrum, Fakultni nemocnice Kralovske Vinohrady


ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Italy
Brazil
Netherlands
Spain
France
Poland
Hungary
Portugal
Germany
United Kingdom

location_facility: U.O.C. Psichiatria dello Sviluppo IRCCS Fondazione Stella Maris

location_facility: Hôpital Robert Debré Service de Psychiatrie de l'enfant et de l'adolescent

location_facility: Faculdade de Medicina da Universidade de São Paulo - Departamento de Psiquiatria

location_facility: Centrum Badań Klinicznych PI-House sp. z o.o

location_facility: Niepubliczny Zakład Opieki Zdrowotnej Gdańskie Centrum Zdrowia Sp. z o.o.

location_facility: Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

location_facility: Universidade Federal de São Paulo, Escola Paulista de Medicina

location_facility: Centre Hospitalier du Rouvray Centre de Ressources pour l'Autisme

location_facility: Centro Hospitalar e Universitario de Coimbra Hospital Pediatrico

location_facility: Universitätsklinikum Freiburg, Zentrum für Psychische Erkrankungen, Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter

location_facility: Unità Semplice di Psichiatria Infantile Policlinico Universitario di Napoli - Università Federico II

location_facility: Samodzielny Publiczny Dziecięcy Szpital Kliniczny w Warszawie Oddział Kliniczny Psychiatrii Wieku Rozwojowego

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden, Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und

location_facility: Programma Interdipartimentale "Autismo 0-90" A.O.U. Policlinico "Gaetano Martino"

location_facility: Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters am Zentralinstitut für Seelische Gesundheit

location_facility: Neuro Riabilitazione/Psicopatologia dell'età evolutiva Istituto Scientifico Medea - Bosisio Parini

location_facility: Szegedi Tudományegyetem Szent-Gyorgy Albert Klinikai Kozpont Gyermekgyógyászati Klinika Gyermek es Ifjusagpszichiátriai o

location_facility: Bekes Megyei Kozponti Korhaz Gyermek es ifjusagpszichiatriai osztaly

location_facility: U.O. di Neuropsichiatria Infantile Fondazione Istituto Neurologico Nazionale Casimiro Mondino Istituto di Ricovero e Cura a Carattere Scientifico

location_facility: Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza Ospedale Pediatrico-Microcitemico

location_facility: U.O. di Neuropsichiatria Infantile Azienda Ospedaliera Universitaria Senese

location_facility: Forward Thinking Birmingham_Birmingham Women's and Children's NHS Foundation Trust

location_facility: Trial Tech em Pesquisas com Medicamentos Ltda

location_facility: Hôpitaux Universitaires de Strasbourg Service de Psychiatrie de l'Enfant et de l'Adolescent

location_facility: Centre Hospitalier Charles Perrens CRA Aquitaine

location_facility: NAVICULA Centrum Diagnozy i Terapii Autyzmu w Łodzi

location_facility: Hôpital Le Vinatier CRA Rhône-Alpes, Bat 211

title: A 6-month Randomised, Double-blind, Placebo Controlled Multicentre Parallel Group Study to Evaluate Efficacy and Safety of Bumetanide 0.5mg Twice a Day Followed by an Open Label Active 6-month Treatment Period With Bumetanide (0.5mg Twice a Day) and a 6 Weeks Discontinuation Period After Treatment Stop.

summary: The purpose of this study is to evaluate the efficacy and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.


title: Long Term Follow-up of Twisted Fallopian Tubes Among Young Girl. International Study

acronym: Tubes

summary:
Isolated tubal torsion is a very rare event already in adults (1: 1.5 million women), it remains exceptional in children without being able to find a prevalence in the literature. The causes can be malformative or idiopathic, but even that remains unknown.

Because of the scarcity, surgical treatment is not standardized and left to the good care of the surgeon in charge.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Hospices Civils de Lyon

location_country: Italy Lebanon France Romania Turkey

location_facility: ASP Trapani - presidio ospedaliero "S. Antonio Abate

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Institute for Maternal and Child Health IRCCS G. Gaslini, Genova

location_facility: Ege University Faculty of Medicine Children's Hospital

location_facility: Centre Hospitalier Universitaire de Angers

location_facility: APHM, Hôpital La Timone Enfants et Hôpital Nord

location_facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo

intervention_type: Procedure


ReferenceCitation: Gullaksen SE, Skavland J, Gavasso S, Tosevski V, Warzocha K, Dumrese C, Ferrant A, Gedde-Dahl T, Hellmann A, Janssen J, Labar B, Lang A, Majeed W, Mihaylov G, Stentoft J, Stenke L, Thaler J, Thielen N, Verhoef G, Voglova J, Ossenkoppele G, Hochhaus A, Hjorth-Hansen H, Mustjoki S, Sopper S, Giles F, Porkka K, Wolf D, Gjertsen BT. Single cell immune profiling by mass cytometry of newly diagnosed chronic phase chronic myeloid leukemia treated with nilotinib. Haematologica. 2017 Aug;102(8):1361-1367. doi: 10.3324/haematol.2017.167080. Epub 2017 May 18.

family: Gullaksen

full_name: Stein-Erik Gullaksen

given: Stein-Erik

family: Skavland

full_name: Jørn Skavland

given: Jørn

family: Gavasso

full_name: Sonia Gavasso

given: Sonia

family: Tosevski

full_name: Vinko Tosevski

given: Vinko

family: Warzocha

full_name: Krzysztof Warzocha

given: Krzysztof

family: Dumrese

full_name: Claudia Dumrese

given: Claudia

family: Ferrant

full_name: Augustin Ferrant

given: Augustin

family: Gedde-Dahl

full_name: Tobias Gedde-Dahl

given: Tobias

family: Hellmann

full_name: Andrzej Hellmann

given: Andrzej

family: Janssen

full_name: Jeroen Janssen

given: Jeroen

family: Labar

full_name: Boris Labar

given: Boris

family: Lang

full_name: Alois Lang

given: Alois

family: Majeed

full_name: Waleed Majeed

given: Waleed

family: Mihaylov

full_name: Georgi Mihaylov

given: Georgi

family: Stentoft

full_name: Jesper Stentoft

given: Jesper

family: Stenke

full_name: Leif Stenke

given: Leif

family: Thaler

full_name: Josef Thaler

given: Josef

family: Thielen

full_name: Noortje Thielen

given: Noortje

family: Verhoef

full_name: Gregor Verhoef

given: Gregor

family: Voglova

full_name: Jaroslava Voglova

given: Jaroslava

family: Ossenkoppele

full_name: Gert Ossenkoppele

given: Gert

family: Hochhaus

full_name: Andreas Hochhaus

given: Andreas

family: Hjorth-Hansen

full_name: Henrik Hjorth-Hansen

given: Henrik

family: Mustjoki

full_name: Satu Mustjoki

given: Satu

family: Sopper

full_name: Sieghart Sopper

given: Sieghart

repository_institution: University of Oslo - Duo Research Archive

repository_normalized: HELDA - Digital Repository of the University of Helsinki

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Thielen N, Richter J, Baldauf M, Barbany G, Fioretos T, Giles F, Gjertsen BT, Hochhaus A, Schuurhuis GJ, Sopper S, Stenke L, Thunberg S, Wolf D, Ossenkoppele G, Porkka K, Janssen J, Mustjoki S. Leukemic Stem Cell Quantification in Newly Diagnosed Patients With Chronic Myeloid Leukemia Predicts Response to Nilotinib Therapy. Clin Cancer Res. 2016 Aug 15;22(16):4030-8. doi: 10.1158/1078-0432.CCR-15-2791. Epub 2016 Mar 22.

publisher: American Association for Cancer Research (AACR)

location_country:
Finland
Greece
Romania
Belgium
Denmark
Czech Republic
Croatia
France
Lithuania
Poland
Slovakia
Norway
Slovenia
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Portugal
Germany
United Kingdom
Italy
Austria
Spain
Estonia
Latvia

title: A Phase IIIb, Multicentre, Open-label Study of Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome and/or BCR-ABL Positive CML in Chronic Phase

summary: This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.


title: Randomized Control Study : Evaluation of the Benefits of Glucose Drinks During Childbirth

acronym: SOLISO

summary:
Fear of full stomach when emergency general anaesthesia is required is the origin of fastening when giving birth. This behaviour does not warranty perfect security for the general anaesthesia. In addition, well being for women and new born is affected. Giving birth is finally compared to a sportive competition with high-energy needs. As Intravenous energy intake is not regulated by physiologic digestion, it can induce metabolic disorders for the mother that can be amplified for the foetus.

Oral glucose drinks could offer some benefits:

gastric acidity would be decreased without significant increase in volumes.
energy intake would further more active and more efficiency labour
an increase in foetus well being

However, it has never been shown yet that such behaviour could offer those benefits. Also, it seems that there is not more vomiting, but most of the studies compared oral glucose intake to waterborne intake with the same volumes The expected efficacy is a reduction in labour duration and a reduction in percentage of extraction. Previous studies said that the lack of statistical power due to small number of subjects caused the absence of statistical significant relationship.

In addition, even though newborn have less acidosis, there is no clinical relationship proven.

The investigators propose a randomised multicentre study to assess efficacy of oral glucose drinks in comparison to traditional fastening when giving birth.

Main objective is to significantly reduce instrumental extraction rates. 5400 women will be included in the study in 2 years.

lead_sponsor: University Hospital, Caen

location_facility: Centre Hospitalier Mémorial France Etats-Unis

intervention_type: Other


title: Interest of Pre-hospital Administration of Lyophilized Plasma to Prevent or Treat Coagulopathy Associated With Post-traumatic Hemorrhagic Shock (PREHO-PLYO Study )

acronym: PREHO-PLYO

summary:
In severe bleeding due to trauma, a decrease in coagulation factors maintains and promotes bleeding. The plasma allows, through its contribution of coagulation factors, early prevention or correction of this post-trauma induced coagulopathy. This study aims to measure the effectiveness of pre-hospital FLYP administration in case of traumatic hemorrhagic shock, in the occurrence or the treatment of a post traumatic induced coagulopathy.

Study Design

This is a randomized controlled multicenter open label study in two parallel groups.

Eligibility criteria : adult, victim of a hemorrhagic shock of traumatic origin with [systolic blood pressure <70 mmHg] or Shock Index >1.1 The patients will receive either FLYP either the usual treatment as given in the recommendations for best practice.

The primary endpoint is the International Normalized Ratio (INR) at hospital admission.

The study must confirm the link between causality of early administration of plasma in improving post-traumatic coagulopathy. The study must show safe usage in out-of-hospital situations and the ability of medical staff to meet the requirements of the health authorities in terms of product use as well as in terms of traceability of the victims and the treatment they received.

ReferenceCitation: Boutonnet M, Pasquier P, Salvadori A, Auroy Y, Tourtier JP. Advocacy to extend the use of continuous noninvasive hemoglobin measurement. Crit Care Med. 2011 Dec;39(12):2783-4; author reply 2784-5. doi: 10.1097/CCM.0b013e31822b3a22.

ReferenceCitation: Pasquier P, Boutonnet M, Giraud N, Salvadori A, Tourtier JP. Hypotension redefined, shock index and massive transfusion. J Trauma. 2011 Sep;71(3):784-5. doi: 10.1097/TA.0b013e318228b83d.

ReferenceCitation: Brohi K, Singh J, Heron M, Coats T. Acute traumatic coagulopathy. J Trauma. 2003 Jun;54(6):1127-30.

ReferenceCitation: Martinaud C, Tourtier JP, Pasquier P, Ausset S, Sailliol A. The French freeze-dried plasma. J Trauma. 2011 Oct;71(4):1091-2. doi: 10.1097/TA.0b013e31822a8fd5.

ReferenceCitation: Martinaud C, Ausset S, Deshayes AV, Cauet A, Demazeau N, Sailliol A. Use of freeze-dried plasma in French intensive care unit in Afghanistan. J Trauma. 2011 Dec;71(6):1761-4; discussion 1764-5. doi: 10.1097/TA.0b013e31822f1285.

ReferenceCitation: Sailliol A, Martinaud C, Cap AP, Civadier C, Clavier B, Deshayes AV, Mendes AC, Pouget T, Demazeau N, Chueca M, Martelet FR, Ausset S. The evolving role of lyophilized plasma in remote damage control resuscitation in the French Armed Forces Health Service. Transfusion. 2013 Jan;53 Suppl 1:65S-71S. doi: 10.1111/trf.12038.

ReferenceCitation: Martinaud C, Civadier C, Ausset S, Verret C, Deshayes AV, Sailliol A. In vitro hemostatic properties of French lyophilized plasma. Anesthesiology. 2012 Aug;117(2):339-46. doi: 10.1097/ALN.0b013e3182608cdd.

ReferenceCitation: Glassberg E, Nadler R, Gendler S, Abramovich A, Spinella PC, Gerhardt RT, Holcomb JB, Kreiss Y. Freeze-dried plasma at the point of injury: from concept to doctrine. Shock. 2013 Dec;40(6):444-50. doi: 10.1097/SHK.0000000000000047. Review. Erratum in: Shock. 2014 Feb;41(2):172.

ReferenceCitation: Brown JB, Guyette FX, Neal MD, Claridge JA, Daley BJ, Harbrecht BG, Miller RS, Phelan HA, Adams PW, Early BJ, Peitzman AB, Billiar TR, Sperry JL. Taking the Blood Bank to the Field: The Design and Rationale of the Prehospital Air Medical Plasma (PAMPer) Trial. Prehosp Emerg Care. 2015 Jul-Sep;19(3):343-50. doi: 10.3109/10903127.2014.995851. Epub 2015 Feb 6.

ReferenceCitation: Kim BD, Zielinski MD, Jenkins DH, Schiller HJ, Berns KS, Zietlow SP. The effects of prehospital plasma on patients with injury: a prehospital plasma resuscitation. J Trauma Acute Care Surg. 2012 Aug;73(2 Suppl 1):S49-53. doi: 10.1097/TA.0b013e31826060ff.

ReferenceCitation: Chapman MP, Moore EE, Moore HB, Gonzalez E, Morton AP, Chandler J, Fleming CD, Ghasabyan A, Silliman CC, Banerjee A, Sauaia A. The "Death Diamond": Rapid thrombelastography identifies lethal hyperfibrinolysis. J Trauma Acute Care Surg. 2015 Dec;79(6):925-9. doi: 10.1097/TA.0000000000000871.

ReferenceType: result

ReferenceCitation: Floccard B, Rugeri L, Faure A, Saint Denis M, Boyle EM, Peguet O, Levrat A, Guillaume C, Marcotte G, Vulliez A, Hautin E, David JS, Négrier C, Allaouchiche B. Early coagulopathy in trauma patients: an on-scene and hospital admission study. Injury. 2012 Jan;43(1):26-32. doi: 10.1016/j.injury.2010.11.003. Epub 2010 Nov 26.

family: Floccard

full_name: Bernard Floccard

given: Bernard

family: Rugeri

full_name: Lucia Rugeri

given: Lucia

family: Faure

full_name: Alexandre Faure

given: Alexandre

family: Denis

full_name: Marc Saint Denis

given: Marc Saint

family: Boyle

full_name: Eileen Mary Boyle

given: Eileen Mary

family: Peguet

full_name: Olivier Peguet

given: Olivier

family: Levrat

full_name: Albrice Levrat

given: Albrice

family: Guillaume

full_name: Christian Guillaume

given: Christian

family: Marcotte

full_name: Guillaume Marcotte

given: Guillaume

family: Vulliez

full_name: Alexandre Vulliez

family: Hautin

full_name: Etienne Hautin

given: Etienne

family: David

full_name: Jean Stéphane David

given: Jean Stéphane

family: Négrier

full_name: Claude Négrier

given: Claude

family: Allaouchiche

full_name: Bernard Allaouchiche

journal_name: Injury

title: Early coagulopathy in trauma patients: An on-scene and hospital admission study

ReferenceCitation: Borgman MA, Spinella PC, Perkins JG, Grathwohl KW, Repine T, Beekley AC, Sebesta J, Jenkins D, Wade CE, Holcomb JB. The ratio of blood products transfused affects mortality in patients receiving massive transfusions at a combat support hospital. J Trauma. 2007 Oct;63(4):805-13.

ReferenceCitation: de Biasi AR, Stansbury LG, Dutton RP, Stein DM, Scalea TM, Hess JR. Blood product use in trauma resuscitation: plasma deficit versus plasma ratio as predictors of mortality in trauma (CME). Transfusion. 2011 Sep;51(9):1925-32. doi: 10.1111/j.1537-2995.2010.03050.x. Epub 2011 Feb 18.

family: de Biasi

full_name: Andreas R. de Biasi

given: Andreas R.

family: Stansbury

full_name: Lynn G. Stansbury

given: Lynn G.

family: Dutton

full_name: Richard P. Dutton

given: Richard P.

family: Stein

full_name: Deborah M. Stein

ReferenceCitation: Peltan ID, Vande Vusse LK, Maier RV, Watkins TR. An International Normalized Ratio-Based Definition of Acute Traumatic Coagulopathy Is Associated With Mortality, Venous Thromboembolism, and Multiple Organ Failure After Injury. Crit Care Med. 2015 Jul;43(7):1429-38. doi: 10.1097/CCM.0000000000000981.

title: An International Normalized Ratio–Based Definition of Acute Traumatic Coagulopathy Is Associated With Mortality, Venous Thromboembolism, and Multiple Organ Failure After Injury

ReferenceCitation: Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.

name: Center for Translational Injury Research, Division of Acute Care Surgery, Department of Surgery, Medical School, University of Texas Health Science Center, Houston

name: Division of Biostatistics, School of Public Health, University of Texas Health Science Center, Houston

name: Division of Trauma and Critical Care, Department of Surgery, Medical College of Wisconsin, Milwaukee22Dr Brasel is now with the Division of Trauma, Critical Care and Acute Care Surgery, School of Medicine, Oregon Health & Science University, Portland

name: Division of Trauma and Critical Care, Department of Surgery, School of Medicine, University of Washington, Seattle

name: Division of General Surgery, Department of Surgery, School of Medicine, University of California, San Francisco

name: Division of Trauma and Surgical Critical Care, Department of Surgery, College of Medicine, University of Tennessee Health Science Center, Memphis

name: Division of Trauma and Critical Care, University of Southern California, Los Angeles

name: Division of Trauma, Burns and Surgical Critical Care, Department of Surgery, School of Medicine, University of Alabama, Birmingham

name: Division of Trauma/Critical Care, Department of Surgery, College of Medicine, University of Cincinnati, Cincinnati, Ohio23Dr Muskat is now with the Division of General Surgery, Department of Surgery, School of Medicine, University of California, San Franc

name: Division of Trauma, Critical Care and Emergency Surgery, Department of Surgery, University of Arizona, Tucson

name: Trauma and Acute Care Surgery, St Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada

name: R. Adams Cowley Shock Trauma Center, Program in Trauma, University of Maryland School of Medicine, Baltimore

name: Sunnybrook Research Institute, Department of Clinical Pathology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

name: Department of Laboratory Medicine, School of Medicine, University of Washington, Seattle

name: Department of Emergency Medicine, College of Medicine, University of Cincinnati, Cincinnati, Ohio

name: Division of Critical Care and Perioperative Medicine, Department of Anesthesiology, School of Medicine, University of Alabama, Birmingham

name: American College of Surgeons, Chicago, Illinois

name: Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland

name: Department of Biostatistics, School of Public Health, University of Washington, Seattle21Department of Environmental and Occupational Health Sciences, School of Public Health, University of Washington, Seattle

title: Transfusion of Plasma, Platelets, and Red Blood Cells in a 1:1:1 vs a 1:1:2 Ratio and Mortality in Patients With Severe Trauma

ReferenceCitation: Sunde GA, Vikenes B, Strandenes G, Flo KC, Hervig TA, Kristoffersen EK, Heltne JK. Freeze dried plasma and fresh red blood cells for civilian prehospital hemorrhagic shock resuscitation. J Trauma Acute Care Surg. 2015 Jun;78(6 Suppl 1):S26-30. doi: 10.1097/TA.0000000000000633.

journal_name: Journal of Trauma and Acute Care Surgery

ReferenceCitation: Moore HB, Moore EE, Morton AP, Gonzalez E, Fragoso M, Chapman MP, Dzieciatkowska M, Hansen KC, Banerjee A, Sauaia A, Silliman CC. Shock-induced systemic hyperfibrinolysis is attenuated by plasma-first resuscitation. J Trauma Acute Care Surg. 2015 Dec;79(6):897-903; discussion 903-4. doi: 10.1097/TA.0000000000000792.

ReferenceCitation: Rugeri L, Levrat A, David JS, Delecroix E, Floccard B, Gros A, Allaouchiche B, Negrier C. Diagnosis of early coagulation abnormalities in trauma patients by rotation thrombelastography. J Thromb Haemost. 2007 Feb;5(2):289-95. Epub 2006 Nov 16.

ReferenceCitation: Jost D, Lemoine S, Lemoine F, Lanoe V, Maurin O, Derkenne C, Franchin Frattini M, Delacote M, Seguineau E, Godefroy A, Hervault N, Delhaye L, Pouliquen N, Louis-Delauriere E, Trichereau J, Roquet F, Salomé M, Verret C, Bihannic R, Jouffroy R, Frattini B, Hong Tuan Ha V, Dang-Minh P, Travers S, Bignand M, Martinaud C, Garrabe E, Ausset S, Prunet B, Sailliol A, Tourtier JP; PREHO-PLYO Study Group. French lyophilized plasma versus normal saline for post-traumatic coagulopathy prevention and correction: PREHO-PLYO protocol for a multicenter randomized controlled clinical trial. Trials. 2020 Jan 22;21(1):106. doi: 10.1186/s13063-020-4049-1.

location_facility: Hopital des Instructions des Armées BEGIN

location_facility: Bataillon des marins-pompiers de Marseille

location_facility: Centre de Transfusion Sanguine des Armées

location_facility: Fire Brigade Of Paris Emergency Medicine Dept

location_facility: Hopital d'Instruction des Armées LAVERAN