Weight-Adjusted vs Fixed Low Doses of Low Molecular Weight Heparin For Venous Thromboembolism Prevention in COVID-19
Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
Summary
Worldwide observational studies indicate a significant prothrombogenic effect associated with
SARS-CoV-2 infection with a high incidence of venous thromboembolism (VTE), notably
life-threatening pulmonary embolism.
According to recommendations for acute medical illnesses, all COVID-19 hospitalized patients
should be given VTE prophylaxis such as a low molecular weight heparin (LMWH). A standard
prophylactic dose (eg. Enoxaparin 4000IU once daily) could be insufficient in obese patients
and VTE has been reported in patients treated with a standard prophylactic dose.
In COVID-19 patients, guidelines from several international societies confirm the existence
of an hypercoagulability and the importance of thromboprophylaxis but the "optimal dose is
unknown" and comparative studies are needed.
In view of these elements, carrying out a trial comparing various therapeutic strategies for
the prevention of VTE in hospitalized patients with COVID-19 constitutes a health emergency.
Thus, we hypothesize that an increased prophylactic dose of weight-adjusted LMWH would be
greater than a lower prophylactic dose of LMWH to reduce the risk of life-threatening VTE in
hospitalized patients. The benefit-risk balance of this increase dose will be carefully
evaluated because of bleeding complications favored by possible renal / hepatic dysfunctions,
drug interactions or invasive procedures in COVID-19 patients.
This multicenter randomized (1:1) open-label controlled trial will randomize hospitalized
adults with COVID-19 infection to weight-adjusted prophylactic dose vs. lower prophylactic
dose of LMWH.
Phase:
Phase 4
Details
Lead Sponsor:
Central Hospital, Nancy, France
Collaborators:
Grand Est Region Ministry of Health, France University Hospital of Saint-Etienne