Status:
WITHDRAWN
Concentration-effect Relationship of Enoxaparin for Thromboembolic Prevention
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
CHU Saint-Etienne - Laboratoire de Pharmacologie - Toxicologie - Gaz du sang
Conditions:
Sars-CoV2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients with COVID-19 have special demographic characteristics including thromboembolic risk factors . The pharmacokinetics of enoxaparin administered subcutaneously in the intensive care unit patie...
Detailed Description
D-dimers greater than 1 μg/mL are a prognostic factor for 28-day mortality (odds ratio=18, 2-128). The use of preventive doses of enoxaparin (4,000 to 6,000 anti-Xa per day) or unfractionated heparin ...
Eligibility Criteria
Inclusion
- Aged \> 18 ans
- SARS-CoV-2 infected intensive care unit patients
- Diagnosis of SARS-CoV-2 respiratory infection was made with a nasopharyngeal swab or a deep respiratory specimen.
- Patient receiving enoxaparin treatment as part of care or as part of a clinical trial for the prevention or treatment of thromboembolic venous disease.
- Patient affiliated or entitled to a social security scheme
Exclusion
- Creatinine clearance according to Cockcroft and Gault \<30ml/min.
- Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWHs)
- History of immune-mediated heparin-induced thrombocytopenia (HIT) in the last 100 days or in the presence of circulating antibodies
- Active clinically significant bleeding or a condition associated with a high risk of bleeding, such as a recent hemorrhagic stroke, gastrointestinal ulcer, the presence of a malignant tumour at high risk of bleeding, recent brain, spinal or ophthalmologic surgery, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysm or major intrarachidian or intracerebral vascular abnormalities.
- Spinal, epidural or locoregional anaesthesia or anaesthesia when enoxaparin sodium is used for curative treatment within the previous 24 hours
Key Trial Info
Start Date :
May 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04520620
Start Date
May 2 2020
End Date
July 10 2020
Last Update
August 20 2020
Active Locations (4)
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1
Groupement Hospitalier des portes de Province
Montélimar, France
2
Centre Hospitalier de Roanne
Roanne, France
3
CHU de Saint-Etienne
Saint-Etienne, France
4
Clinique Mutualiste
Saint-Etienne, France