Title
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
Phase
Phase 4Lead Sponsor
University of GreifswaldStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Heparin-Induced ThrombocytopeniaIntervention/Treatment
heparin ...Study Participants
600Randomised, double blind trial in non-intensive care trauma patients comparing unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) in heparin-induced thrombocytopenia (HIT).
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.
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
