Heparin-Induced Thrombocytopenia Clinical Trial
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
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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