The HIT-TRAP Trial
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|ClinicalTrials.gov Identifier: NCT00196417|
Recruitment Status : Unknown
Verified September 2005 by University Medicine Greifswald.
Recruitment status was: Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
|Condition or disease||Intervention/treatment||Phase|
|Heparin-Induced Thrombocytopenia||Drug: Standard heparin (UFH) versus certoparin (LMWH)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||January 2003|
|Estimated Study Completion Date :||November 2005|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196417
|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|