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Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19

Authors :
Goligher, Ewan C
Bradbury, Charlotte A
McVerry, Bryan J
Lawler, Patrick R
Berger, Jeffrey S
Gong, Michelle N
Carrier, Marc
Reynolds, Harmony R
Kumar, Anand
Turgeon, Alexis F
Kornblith, Lucy Z
Kahn, Susan R
Marshall, John C
Kim, Keri S
Houston, Brett L
Derde, Lennie PG
Cushman, Mary
Tritschler, Tobias
Angus, Derek C
Godoy, Lucas C
McQuilten, Zoe
Kirwan, Bridget-Anne
Farkouh, Michael E
Brooks, Maria M
Lewis, Roger J
Berry, Lindsay R
Lorenzi, Elizabeth
Gordon, Anthony C
Berry, Scott M
McArthur, Colin J
Neal, Matthew D
Hochman, Judith S
Webb, Steven A
Zarychanski, Ryan
Ahuja, Tania
Al-Beidh, Farah
Annane, Djillali
Arabi, Yaseen M
Aryal, Diptesh
Kreuziger, Lisa Baumann
Beane, Abi
Bhimani, Zahra
Bihari, Shailesh
Billett, Henny H
Bond, Lindsay
Bonten, Marc
Brunkhorst, Frank
Buxton, Meredith
Buzgau, Adrian
Castellucci, Lana A
Chekuri, Sweta
Chen, Jen-Ting
Cheng, Allen C
Chkhikvadze, Tamta
Coiffard, Benjamin
Contreras, Aira
Costantini, Todd W
de Brouwer, Sophie
Detry, Michelle A
Duggal, Abhijit
Dzavik, Vladimir
Effron, Mark B
Eng, Heather F
Escobedo, Jorge
Estcourt, Lise J
Everett, Brendan M
Fergusson, Dean A
Fitzgerald, Mark
Fowler, Robert A
Froess, Joshua D
Fu, Zhuxuan
Galanaud, Jean P
Galen, Benjamin T
Gandotra, Sheetal
Girard, Timothy D
Goodman, Andrew L
Goossens, Herman
Green, Cameron
Greenstein, Yonatan Y
Gross, Peter L
Haniffa, Rashan
Hegde, Sheila M
Hendrickson, Carolyn M
Higgins, Alisa M
Hindenburg, Alexander A
Hope, Aluko A
Horowitz, James M
Horvat, Christopher M
Huang, David T
Hudock, Kristin
Hunt, Beverley J
Husain, Mansoor
Hyzy, Robert C
Jacobson, Jeffrey R
Jayakumar, Devachandran
Keller, Norma M
Khan, Akram
Kim, Yuri
Kindzelski, Andrei
King, Andrew J
Kornblith, Aaron E
Kutcher, Matthew E
Laffan, Michael A
Lamontagne, Francois
Le Gal, Gregoire
Leeper, Christine M
Leifer, Eric S
Lim, George
Lima, Felipe Gallego
Linstrum, Kelsey
Litton, Edward
Lopez-Sendon, Jose
Lother, Sylvain A
Marten, Nicole
Marinez, Andrea Saud
Martinez, Mary
Garcia, Eduardo Mateos
Mavromichalis, Stavroula
McAuley, Daniel F
McDonald, Emily G
McGlothlin, Anna
McGuinness, Shay P
Middeldorp, Saskia
Montgomery, Stephanie K
Mouncey, Paul R
Murthy, Srinivas
Nair, Girish B
Nair, Rahul
Nichol, Alistair D
Nicolau, Jose C
Nunez-Garcia, Brenda
Park, John J
Park, Pauline K
Parke, Rachael L
Parker, Jane C
Parnia, Sam
Paul, Jonathan D
Pompilio, Mauricio
Quigley, John G
Rosenson, Robert S
Rost, Natalia S
Rowan, Kathryn
Santos, Fernanda O
Santos, Marlene
Santos, Mayler O
Satterwhite, Lewis
Saunders, Christina T
Schreiber, Jake
Schutgens, Roger EG
Seymour, Christopher W
Siegal, Deborah M
Silva, Delcio G
Singhal, Aneesh B
Slutsky, Arthur S
Solvason, Dayna
Turner, Anne M
Van Bentum-Puijk, Wilma
van de Veerdonk, Frank L
van Diepen, Sean
Vazquez-Grande, Gloria
Wahid, Lana
Wareham, Vanessa
Widmer, R Jay
Wilson, Jennifer G
Yuriditsky, Eugene
Zhong, Yongqi
Investigators, REMAP-CAP
Investigators, ACTIV-4a
Investigators, ATTACC
NIHR
National Institute for Health Research
Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)
National Institutes of Health, NIH: 1OT2HL156812-01, AR7-162822, OTA-20-011, RP-2015-06-18
National Heart, Lung, and Blood Institute, NHLBI
Amgen
CancerCare Manitoba Foundation, CCMF
University of Manitoba, UM
Health Research Board, HRB: CTN 2014-012
Canadian Institutes of Health Research, CIHR: 158584, 447335, COVID-19
National Institute for Health Research, NIHR
European Commission, EC: 602525, FP7-HEALTH-2013-INNOVATION
National Health and Medical Research Council, NHMRC: APP1101719, APP1116530
Health Research Council of New Zealand, HRC: 16/631
Eisai
Ministère des Affaires Sociales et de la Santé: PHRC-20-0147
Université Pierre et Marie Curie, UPMC
Horizon 2020: 101003589
NIHR Imperial Biomedical Research Centre, BRC
Minderoo Foundation
REMAP-CAP was supported by the European Union through FP7-HEALTH-2013-INNOVATION: the Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) consortium (grant 602525) and the Horizon 2020 research and innovation program: the Rapid European Covid-19 Emergency Research response (RECOVER) consortium (grant 101003589) and by grants from the Australian National Health and Medical Research Council (APP1101719 and APP1116530), the Health Research Council of New Zealand (16/631), the Canadian Institutes of Health Research (Strategy for Patient-Oriented Research Innovative Clinical Trials Program Grant 158584 and COVID-19 Rapid Research Operating Grant 447335), the U.K. National Institute for Health Research (NIHR) and the NIHR Imperial Biomedical Research Centre, the Health Research Board of Ireland (CTN 2014-012), the UPMC Learning While Doing Program, the Translational Breast Cancer Research Consortium, the French Ministry of Health (PHRC-20-0147), the Minderoo Foundation, Amgen, Eisai, the Global Coalition for Adaptive Research, and the Wellcome Trust Innovations Project (215522). The ATTACC platform was supported by grants from the Canadian Institutes of Health Research, LifeArc, Thistledown Foundation, Research Manitoba, CancerCare Manitoba Foundation, Victoria General Hospital Foundation, Ontario Ministry of Health, and the Peter Munk Cardiac Centre. The ACTIV-4a platform was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) and administered through OTA-20-011 and was supported in part by NIH agreement 1OT2HL156812-01. Dr. Goligher is the recipient of an Early Career Investigator award from the Canadian Institutes of Health Research (grant AR7-162822). Dr. Gordon is funded by an NIHR Research Professorship (RP-2015-06-18). Dr. Turgeon is funded by a Canada Research Chair-Tier 2. Dr. Zarychanski is the recipient of the Lyonel G. Israels Research Chair in Hematology (University of Manitoba).
Vascular Medicine
ACS - Pulmonary hypertension & thrombosis
Investigators, REMAP-CAP
Investigators, ACTIV-4a
Investigators, ATTACC
REMAP-CAP Investigators
ACTIV-4a Investigators
ATTACC Investigators
Source :
New England Journal of Medicine, New England Journal of Medicine, Massachusetts Medical Society, 2021, 385 (9), pp.777-789. ⟨10.1056/NEJMoa2103417⟩, New England journal of medicine, 385(9), 777-789. Massachussetts Medical Society, et al. 2021, ' Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19 ', New England Journal of Medicine, vol. 385, no. 9, pp. 777-789 . https://doi.org/10.1056/NEJMoa2103417, NEW ENGLAND JOURNAL OF MEDICINE, The New England Journal of Medicine, 385, 9, pp. 777-789, Investigators, REMAP-CAP & Dark, P 2021, ' Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19 ', The New England Journal of Medicine, vol. 385, no. 9, pp. 777-789 . https://doi.org/10.1056/NEJMoa2103417, The New England Journal of Medicine, 385, 777-789, The New England journal of medicine
Publication Year :
2021

Abstract

BACKGROUNDThrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19.METHODSIn an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support–free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of −1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge.RESULTSThe trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support–free days was 1 (interquartile range, −1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, −1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio CONCLUSIONSIn critically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin did not result in a greater probability of survival to hospital discharge or a greater number of days free of cardiovascular or respiratory organ support than did usual-care pharmacologic thromboprophylaxis. (REMAP-CAP, ACTIV-4a, and ATTACC ClinicalTrials.gov numbers, NCT02735707. opens in new tab, NCT04505774. opens in new tab, NCT04359277. opens in new tab, and NCT04372589. opens in new tab.)

Details

ISSN :
00284793 and 15334406
Volume :
385
Database :
OpenAIRE
Journal :
The New England Journal of Medicine
Accession number :
edsair.doi.dedup.....85dfa0ff9303f71a226cade0fe2e7521