The HIT-TRAP Trial
This trial is active, not recruiting.
|Treatment||standard heparin (ufh) versus certoparin (lmwh)|
|Sponsor||University Medicine Greifswald|
|Start date||January 2003|
|End date||November 2005|
|Trial size||600 participants|
|Trial identifier||NCT00196417, 001|
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).
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
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
Male or female participants at least 18 years old.
Inclusion Criteria: - trauma-surgical patient - consent given - minimum age 18 - expected inpatient period at least 7 days - need for thrombosis prophylaxis with heparin Exclusion Criteria: - intolerance of one of the study drugs - malignancy with life expectancy < 3 months - pregnancy/lactation - drug or alcohol abuse - fibrinolytic therapy - need for extracorporal circulation (e.g. cardiopulm. bypass, hemodialysis) at study entry - participation in another clinical trial within 30 days prior to intended inclusion
|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|
|Principal investigator||Andreas Greinacher, Prof. Dr.|
|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.|
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