Journal article
Standard prophylactic versus intermediate dose enoxaparin in adults with severe COVID‐19: A multi‐center, open‐label, randomized controlled trial
Journal of thrombosis and haemostasis, Vol.19(9), pp.2225-2234
09/2021
DOI: 10.1111/jth.15450
PMCID: PMC8420176
PMID: 34236768
Abstract
Background
Coronavirus disease 2019 (COVID‐19) is associated with coagulopathy but the optimal prophylactic anticoagulation therapy remains uncertain and may depend on COVID‐19 severity.
Objective
To compare outcomes in hospitalized adults with severe COVID‐19 treated with standard prophylactic versus intermediate dose enoxaparin.
Methods
We conducted a multi‐center, open‐label, randomized controlled trial comparing standard prophylactic dose versus intermediate dose enoxaparin in adults who were hospitalized with COVID‐19 and admitted to an intensive care unit (ICU) and/or had laboratory evidence of coagulopathy. Patients were randomly assigned in a 1:1 ratio to receive standard prophylactic dose enoxaparin or intermediate weight‐adjusted dose enoxaparin. The primary outcome was all‐cause mortality at 30 days. Secondary outcomes included arterial or venous thromboembolism and major bleeding.
Results
A total of 176 patients (99 males and 77 females) underwent randomization. In the intention‐to‐treat population, all‐cause mortality at 30 days was 15% for intermediate dose enoxaparin and 21% for standard prophylactic dose enoxaparin (odds ratio, 0.66; 95% confidence interval, 0.30–1.45; P = .31 by Chi‐square test). Unadjusted Cox proportional hazards modeling demonstrated no significant difference in mortality between intermediate and standard dose enoxaparin (hazard ratio, 0.67; 95% confidence interval, 0.33–1.37; P = .28). Arterial or venous thrombosis occurred in 13% of patients assigned to intermediate dose enoxaparin and 9% of patients assigned to standard dose enoxaparin. Major bleeding occurred in 2% of patients in each arm.
Conclusion
In hospitalized adults with severe COVID‐19, standard prophylactic dose and intermediate dose enoxaparin did not differ significantly in preventing death or thrombosis at 30 days.
Details
- Title: Subtitle
- Standard prophylactic versus intermediate dose enoxaparin in adults with severe COVID‐19: A multi‐center, open‐label, randomized controlled trial
- Creators
- Usha S. Perepu - University of IowaIsaac Chambers - University of IowaAbdul Wahab - University of IowaPatrick Ten Eyck - University of IowaChaorong Wu - University of IowaSanjana Dayal - University of IowaGrerk Sutamtewagul - University of IowaSteven R. Bailey - Louisiana State University Health Sciences Center ShreveportLori J. Rosenstein - Gundersen Health SystemSteven R. Lentz - University of Iowa
- Resource Type
- Journal article
- Publication Details
- Journal of thrombosis and haemostasis, Vol.19(9), pp.2225-2234
- DOI
- 10.1111/jth.15450
- PMID
- 34236768
- PMCID
- PMC8420176
- NLM abbreviation
- J Thromb Haemost
- ISSN
- 1538-7933
- eISSN
- 1538-7836
- Number of pages
- 10
- Grant note
- National Center for Advancing Translational Sciences (UL1 TR002537)
- Language
- English
- Date published
- 09/2021
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Iowa Neuroscience Institute; Biostatistics; Fraternal Order of Eagles Diabetes Research Center; Internal Medicine
- Record Identifier
- 9984359820902771
Metrics
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