Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19.
Abstract
<h4>Background</h4>Thrombosis 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.<h4>Methods</h4>In
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.<h4>Results</h4>The 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 <1.2], 99.9%). The percentage of patients who
survived to hospital discharge was similar in the two groups (62.7% and 64.5%, respectively;
adjusted odds ratio, 0.84; 95% credible interval, 0.64 to 1.11). Major bleeding occurred
in 3.8% of the patients assigned to therapeutic-dose anticoagulation and in 2.3% of
those assigned to usual-care pharmacologic thromboprophylaxis.<h4>Conclusions</h4>In
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, NCT04505774, NCT04359277, and NCT04372589.).
Type
Journal articlePermalink
https://hdl.handle.net/10161/23608Published Version (Please cite this version)
10.1056/nejmoa2103417Publication Info
REMAP-CAP Investigators; ACTIV-4a Investigators; ATTACC Investigators; Goligher, Ewan
C; Bradbury, Charlotte A; McVerry, Bryan J; ... Zarychanski, Ryan (2021). Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19.
The New England journal of medicine. 10.1056/nejmoa2103417. Retrieved from https://hdl.handle.net/10161/23608.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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Show full item recordScholars@Duke
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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