Status:
COMPLETED
Prevention of Arteriovenous Thrombotic Events in Critically-Ill COVID-19 Patients Trial
Lead Sponsor:
The TIMI Study Group
Conditions:
COVID-19
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The researchers wanted to learn how to help sick patients who are in the hospital because of COVID-19. They are trying to find out the best way that is safe to stop blood clots that could be dangerous...
Detailed Description
This is a multicenter, open-label, randomized-controlled trial in critically-ill patients with novel coronavirus disease 2019 (COVID-19) evaluating the efficacy and safety of full-dose vs. standard pr...
Eligibility Criteria
Inclusion
- Age ≥18 years (male or female)
- Acute infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)
- Currently admitted to an intensive care unit (ICU)
- Key
Exclusion
- Ongoing (\>48 hours) or planned full-dose (therapeutic) anticoagulation for any indication
- Ongoing or planned treatment with dual antiplatelet therapy
- Contraindication to antithrombotic therapy or high risk of bleeding due to conditions including, but not limited to, any of the following:
- History of intracranial hemorrhage, known central nervous system (CNS) tumor or CNS vascular abnormality
- Active or recent major bleeding within the past 30 days with untreated source
- Platelet count \<70,000 or known functional platelet disorder
- Fibrinogen \<200 mg/dL
- International normalized ratio (INR) \>1.9
- History of heparin-induced thrombocytopenia
- Ischemic stroke within the past 2 weeks
- Patients who meet the following criterion are excluded from the second randomization (antiplatelet therapy vs. no antiplatelet therapy):
- 1\. Ongoing or planned antiplatelet therapy, including aspirin monotherapy
Key Trial Info
Start Date :
August 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2022
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT04409834
Start Date
August 5 2020
End Date
March 10 2022
Last Update
January 19 2024
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02459