Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19
REMAP-CAP anticoagulation trial design and results
Design
Open-label adaptive multiplatform randomised trial, stopped for futility
Treatment
Therapeutic-dose anticoagulation with heparin
Control
Usual-care pharmacological thromboprophylaxis
Population
1098 critically ill patients with COVID-19
Follow-up
Hospital discharge
Primary endpoint
Organ support-free days to day 21
Result
Median organ support-free days was 1 (IQR -1 to 16) with therapeutic-dose anticoagulation, with no greater probability of survival to hospital discharge or of organ support-free days than usual-care thromboprophylaxis. The trial was stopped when the prespecified futility criterion was met.
Secondary endpoints
Survival to hospital discharge, major bleeding, thrombotic events
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.
The trial authors, in the published abstract
How it has aged
A necessary correction to the widespread empirical escalation of anticoagulation during the early pandemic, driven by observed thrombosis rates. The same platform found a different answer in moderately ill patients, which is the reason severity stratification appears in every subsequent recommendation.
Publications
Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19
Goligher EC, Bradbury CA, McVerry BJ, et al. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19. N Engl J Med 2021 Aug 26;385(9):777-789.
No increase in organ support-free days
No improvement in survival to hospital discharge
Stopped when the prespecified futility criterion was met