The HIT-TRAP Trial
Recruitment status was Active, not recruiting
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).
Drug: Standard heparin (UFH) versus certoparin (LMWH)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients
- Thromboembolic complications (TECs) during inpatient period in relation to heparin received and HIT-antibody status
- TECs during 3 months following discharge in relation to heparin received and HIT-antibody status
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||November 2005|
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.
|Ernst-Moritz-Arndt University, Depts. of Transfusion Medicine / Trauma surgery|
|Greifswald, Germany, 17489|
|Principal Investigator:||Andreas Greinacher, Prof. Dr.||Ernst-Moritz-Arndt University Greifswald, Germany|