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Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19.

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Date
2021-08-04
Authors
ATTACC Investigators
ACTIV-4a Investigators
REMAP-CAP Investigators
Lawler, Patrick R
Goligher, Ewan C
Berger, Jeffrey S
Neal, Matthew D
McVerry, Bryan J
Nicolau, Jose C
Gong, Michelle N
Carrier, Marc
Rosenson, Robert S
Reynolds, Harmony R
Turgeon, Alexis F
Escobedo, Jorge
Huang, David T
Bradbury, Charlotte A
Houston, Brett L
Kornblith, Lucy Z
Kumar, Anand
Kahn, Susan R
Cushman, Mary
McQuilten, Zoe
Slutsky, Arthur S
Kim, Keri S
Gordon, Anthony C
Kirwan, Bridget-Anne
Brooks, Maria M
Higgins, Alisa M
Lewis, Roger J
Lorenzi, Elizabeth
Berry, Scott M
Berry, Lindsay R
Aday, Aaron W
Al-Beidh, Farah
Annane, Djillali
Arabi, Yaseen M
Aryal, Diptesh
Baumann Kreuziger, Lisa
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
Costantini, Todd W
de Brouwer, Sophie
Derde, Lennie PG
Detry, Michelle A
Duggal, Abhijit
Džavík, Vladimír
Effron, Mark B
Estcourt, Lise J
Everett, Brendan M
Fergusson, Dean A
Fitzgerald, Mark
Fowler, Robert A
Galanaud, Jean P
Galen, Benjamin T
Gandotra, Sheetal
García-Madrona, Sebastian
Girard, Timothy D
Godoy, Lucas C
Goodman, Andrew L
Goossens, Herman
Green, Cameron
Greenstein, Yonatan Y
Gross, Peter L
Hamburg, Naomi M
Haniffa, Rashan
Hanna, George
Hanna, Nicholas
Hegde, Sheila M
Hendrickson, Carolyn M
Hite, R Duncan
Hindenburg, Alexander A
Hope, Aluko A
Horowitz, James M
Horvat, Christopher M
Hudock, Kristin
Hunt, Beverley J
Husain, Mansoor
Hyzy, Robert C
Iyer, Vivek N
Jacobson, Jeffrey R
Jayakumar, Devachandran
Keller, Norma M
Khan, Akram
Kim, Yuri
Kindzelski, Andrei L
King, Andrew J
Knudson, M Margaret
Kornblith, Aaron E
Krishnan, Vidya
Kutcher, Matthew E
Laffan, Michael A
Lamontagne, Francois
Le Gal, Grégoire
Leeper, Christine M
Leifer, Eric S
Lim, George
Lima, Felipe Gallego
Linstrum, Kelsey
Litton, Edward
Lopez-Sendon, Jose
Lopez-Sendon Moreno, Jose L
Lother, Sylvain A
Malhotra, Saurabh
Marcos, Miguel
Saud Marinez, Andréa
Marshall, John C
Marten, Nicole
Matthay, Michael A
McAuley, Daniel F
McDonald, Emily G
McGlothlin, Anna
McGuinness, Shay P
Middeldorp, Saskia
Montgomery, Stephanie K
Moore, Steven C
Morillo Guerrero, Raquel
Mouncey, Paul R
Murthy, Srinivas
Nair, Girish B
Nair, Rahul
Nichol, Alistair D
Nunez-Garcia, Brenda
Pandey, Ambarish
Park, Pauline K
Parke, Rachael L
Parker, Jane C
Parnia, Sam
Paul, Jonathan D
Pérez González, Yessica S
Pompilio, Mauricio
Prekker, Matthew E
Quigley, John G
Rost, Natalia S
Rowan, Kathryn
Santos, Fernanda O
Santos, Marlene
Olombrada Santos, Mayler
Satterwhite, Lewis
Saunders, Christina T
Schutgens, Roger EG
Seymour, Christopher W
Siegal, Deborah M
Silva, Delcio G
Shankar-Hari, Manu
Sheehan, John P
Singhal, Aneesh B
Solvason, Dayna
Stanworth, Simon J
Tritschler, Tobias
Turner, Anne M
van Bentum-Puijk, Wilma
van de Veerdonk, Frank L
van Diepen, Sean
Vazquez-Grande, Gloria
Wahid, Lana
Wareham, Vanessa
Wells, Bryan J
Widmer, R Jay
Wilson, Jennifer G
Yuriditsky, Eugene
Zampieri, Fernando G
Angus, Derek C
McArthur, Colin J
Webb, Steven A
Farkouh, Michael E
Hochman, Judith S
Zarychanski, Ryan
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Abstract
<h4>Background</h4>Thrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.<h4>Methods</h4>In this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care-level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. 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. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level.<h4>Results</h4>The trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support-free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis.<h4>Conclusions</h4>In noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589, NCT04505774, NCT02735707, and NCT04359277.).
Type
Journal article
Subject
ATTACC Investigators
ACTIV-4a Investigators
REMAP-CAP Investigators
Permalink
https://hdl.handle.net/10161/23607
Published Version (Please cite this version)
10.1056/nejmoa2105911
Publication Info
ATTACC Investigators; ACTIV-4a Investigators; REMAP-CAP Investigators; Lawler, Patrick R; Goligher, Ewan C; Berger, Jeffrey S; ... Zarychanski, Ryan (2021). Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19. The New England journal of medicine. 10.1056/nejmoa2105911. Retrieved from https://hdl.handle.net/10161/23607.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Wahid

Lana Wahid

Assistant Professor of Medicine
Health Services Researcher, Clinical TrialistMedical Director of Duke's Early Phase Research Unit (DEPRU)Associate Chief, Hospital-Based Clinical Trials & Research Program
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