Status:
COMPLETED
Weight-Adjusted vs Fixed Low Doses of Low Molecular Weight Heparin For Venous Thromboembolism Prevention in COVID-19
Lead Sponsor:
Central Hospital, Nancy, France
Collaborating Sponsors:
Ministry of Health, France
Grand Est Region
Conditions:
COVID
Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 pulmo...
Eligibility Criteria
Inclusion
- 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
- Renal insufficiency with a GFR\<15 mL/min/1.73m²
- 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
Key Trial Info
Start Date :
May 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2021
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04373707
Start Date
May 13 2020
End Date
September 14 2021
Last Update
August 7 2023
Active Locations (17)
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1
Amiens Academic Hospital
Amiens, France
2
Besançon Academic Hospital
Besançon, France
3
Brest Academic Hospital
Brest, France
4
Civil Hospital
Colmar, France