Status:
COMPLETED
Covid-19 Associated Coagulopathy
Lead Sponsor:
University of Iowa
Conditions:
COVID 19 Associated Coagulopathy
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
This prospective, randomized, open-label, multi-center interventional study is designed to compare the safety and efficacy of two LMWH dosing protocols in patients admitted to the University of Iowa H...
Detailed Description
Potentially eligible patients will be identified by a healthcare professional per institutional policy on privacy. The healthcare professional will assess the eligibility of the patient by performing ...
Eligibility Criteria
Inclusion
- Laboratory confirmed SARS-CoV-2 infection
- Age ≥18 years
- Requires hospital admission for further clinical management
- Modified ISTH Overt DIC score ≥ 3
Exclusion
- Indication for full therapeutic-dose anticoagulation
- Acute venous thromboembolism (deep vein thrombosis or pulmonary embolism) within prior 3 months
- Acute cardiovascular event within prior 3 months
- Acute stroke (ischemic or hemorrhagic) within prior 3 months
- Active major bleeding
- Severe thrombocytopenia (\<25,000/mm3)
- Increased risk of bleeding, as assessed by the investigator
- Acute or chronic renal insufficiency with Creatinine Clearance \< 30 ml/min calculated by the modified Cockcroft and Gault formula
- Weight \< 40 kg
- Known allergies to ingredients contained in enoxaparin, allergy to heparin products or history of heparin induced thrombocytopenia
Key Trial Info
Start Date :
May 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2021
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT04360824
Start Date
May 6 2020
End Date
April 16 2021
Last Update
March 1 2023
Active Locations (2)
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1
University of Iowa
Iowa City, Iowa, United States, 52242
2
Gundersen Health System
La Crosse, Wisconsin, United States, 54601