NCT00196417

The HIT-TRAP Trial

Randomized-Double Blind Trial to Assess the Incidence and Clinical Relevance of Heparin-Induced Thrombocytopenia (HIT) Antibodies in Trauma Patients Treated With Unfractionated or Low-Molecular Weight Heparin, the HIT-TRAP Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (planned)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomised, double blind trial in non-intensive care trauma patients comparing unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) in heparin-induced thrombocytopenia (HIT).

Detailed description

This is a randomised, double blind trial including trauma patients with need for thrombosis prophylaxis with heparin. Patients receive either unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH). Heparin-induced thrombocytopenia (HIT) antibodies are measured on days 1 and 10. There are daily platelet counts. On discharge an ultrasound doppler of the lower extremities is performed to rule out deep vein thrombosis (DVT). Three months after discharge every patient is answering a questionnaire about thromboembolic complications following discharge. The key questions of the study are whether the two heparins cause HIT-antibodies in differing frequencies, and if yes, whether these differences lead to different clinical outcomes.

Conditions

• Heparin-Induced Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Standard heparin (UFH) versus certoparin (LMWH)

Timeline

• Start date: 2003-01-01
• Completion: 2005-11-01
• First posted: 2005-09-20
• Last updated: 2005-09-20

Locations

1 site across 1 country: Germany