Weight-Adjusted vs Fixed Low Doses of Low Molecular Weight Heparin For Venous Thromboembolism Prevention in COVID-19

  • STATUS
    Recruiting
  • End date
    Nov 27, 2021
  • participants needed
    602
  • sponsor
    Central Hospital, Nancy, France
Updated on 27 January 2021
heparin
pneumonia
covid-19
SARS
enoxaparin
PCR test
venous thromboembolism
thrombophilia
thromboembolism
embolism

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
Treatment Enoxaparin
Clinical Study IdentifierNCT04373707
SponsorCentral Hospital, Nancy, France
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: COVID-19 Pneumonia or Corona Virus Disease 2019(COVID-19) or deep venous thrombosis of lower extremity or *COVID-19 or Thrombosis or Lung Disease or B...?
Do you have any of these conditions: Old Age, Usability, Visio Telephony, Confinement, Covid-19 or Anxiety Related to the COVID-19 Pandemic or Covid-19 or Pulmonary Disease or *COVID-19 o...?
Do you have any of these conditions: Acute Respiratory Distress Syndrome Caused by COVID-19 or COVID-19; Cardiovascular Diseases or deep venous thrombosis or COVID-19 Infection or Anxiety...?
Do you have any of these conditions: COVID-19 Pneumonia or Deep Vein Thrombosis or COVID-19; Cardiovascular Diseases or Community-acquired Pneumonia, Influenza, COVID-19 or SARS-CoV-2 (CO...?
Do you have any of these conditions: SARS-CoV-2 (COVID-19) Infection or Pulmonary Embolism or Old Age, Usability, Visio Telephony, Confinement, Covid-19 or *Corona Virus Infection or Path...?
Adult patient hospitalized for a probable/confirmed COVID-19 infection (confirmed by serology/polymerase chain reaction or by radiologic signs of COVID-19 pneumonia in the setting of clinical and laboratory abnormalities suggestive of a SARS-CoV-2 infection)
Signed informed consent
Patient affiliated to the Social Security

Exclusion Criteria

Renal insufficiency with a GFR<15 mL/min/1.73m
Acute kidney injury KDIGO3
Prophylactic dose of low molecular weight heparin for more than 3 days
Curative dose of low molecular weight heparin for more than 1 day
Recurrent catheter/hemodialysis access thromboses
ECMO required in the next 24h
Contraindication to low molecular weight heparin
High bleeding risk (e.g. uncontrolled severe systemic hypertension, recent major bleeding, disseminated intravascular coagulopathy, thrombocytopenia < 75G/L)
History of heparin-induced thrombocytopenia
Contraindication to blood-derived products
Impossibility to perform a doppler ultrasound of the lower limbs (e.g. above the knee amputation, severe burn injuries)
Expected death in the next 48h
Vulnerable subjects according to articles L. 1121-5, L. 1121-7 et L1121-8 of French Public Health Code
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