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Clinical Trial Summary

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).


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00196417
Study type Interventional
Source University Medicine Greifswald
Contact
Status Active, not recruiting
Phase Phase 4
Start date January 2003
Completion date November 2005

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