Weight-Adjusted vs Fixed Low Doses of Low Molecular Weight Heparin For Venous Thromboembolism Prevention in COVID-19
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- STATUS
- Recruiting
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- End date
- Nov 27, 2021
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- participants needed
- 602
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- sponsor
- Central Hospital, Nancy, France
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.
Details
| Condition | Pulmonary Disease, Venous Thrombosis, Pulmonary Embolism, Thrombosis, Blood Clots, Lung Disease, Deep Vein Thrombosis, COVID-19, COVID-19, Coronavirus Disease (COVID-19), COVID-19, COVID-19, Pathogen Infection Covid-19 Infection, *Corona Virus Infection, *COVID-19 Infection, Corona Virus Disease 2019(COVID-19), COVID-19, COVID-19, Treat and Prevent Covid-19 Infection, COVID-19, COVID-19 Infection, *COVID-19, COVID-19, Covid-19, COVID-19, COVID-19 Pneumonia, COVID-19, COVID-19, COVID-19, Covid-19, Pathogen Infection Covid-19 Infection, COVID-19, COVID-19, COVID-19, Use of Stem Cells for COVID-19 Treatment, COVID-19, COVID-19, Hospitalized Patients With Covid-19 Pneumonia, Corona Virus Disease 2019(COVID-19), COVID-19 Pneumonia, COVID-19; Cardiovascular Diseases, Community-acquired Pneumonia, Influenza, COVID-19, Old Age, Usability, Visio Telephony, Confinement, Covid-19, COVID-19 Pneumonia, COVID-19 Pneumonia, Acute Respiratory Distress Syndrome Caused by COVID-19, COVID-19 Pneumonia, Corona Virus Disease 2019(COVID-19), Old Age, Usability, Visio Telephony, Confinement, Covid-19, SARS-CoV-2 (COVID-19) Infection, COVID-19 Pneumonia, Corona Virus Disease 2019(COVID-19), COVID-19 Pneumonia, Severe Coronavirus Disease (COVID-19), Acute Respiratory Distress Syndrome Caused by COVID-19, COVID-19 Pneumonia, COVID-19, Hydroxychloroquine Sulfate, SARS-CoV-2 (COVID-19) Infection, COVID-19 Pneumonia, COVID-19, Hydroxychloroquine Sulfate, Anxiety Related to the COVID-19 Pandemic, Acute Respiratory Distress Syndrome Caused by COVID-19, Severe Coronavirus Disease (COVID-19), COVID-19 Pneumonia, *COVID-19 Infection, Severe Coronavirus Disease (COVID-19), COVID-19 by SARS-CoV-2 Infection, deep venous thrombosis of lower extremity, deep venous thrombosis, clot, lung embolism, blood clotting |
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| Treatment | Enoxaparin |
| Clinical Study Identifier | NCT04373707 |
| Sponsor | Central Hospital, Nancy, France |
| Last Modified on | 27 January 2021 |
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