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HIT-TRAP Trial
NCT00196417Phase 4
Key facts
- Status
- Unknown
- Start
- Jan 2003
- Countries
- 1
- Modality
- Recombinant Proteins and Enzymes, Small Molecules
- Drugs
- certoparinheparin
- Conditions
- thromboembolismdeep vein thrombosis (DVT)
01
Overview
Phase 4, randomised, double-blind trial in thromboembolism and deep vein thrombosis (DVT) comparing Standard heparin (UFH) with Certoparin (LMWH) (2 arms). Primary endpoint: Frequency of formation of HIT-antibodies at Day 10. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Standard heparin (UFH)
Patients receive unfractionated heparin for thrombosis prophylaxis.
Certoparin (LMWH)
Patients receive low-molecular-weight heparin (certoparin) for thrombosis prophylaxis.
03
Who it enrols
Adult trauma-surgical patients requiring inpatient thrombosis prophylaxis with heparin for at least 7 days, excluding those with heparin intolerance, short life expectancy, pregnancy, substance abuse, or requiring extracorporeal circulation.
04
Endpoints
Primary
Frequency of formation of HIT-antibodies
Secondary
Thromboembolic complications during inpatient period
Thromboembolic complications during 3 months following discharge
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