Status:
UNKNOWN
The HIT-TRAP Trial
Lead Sponsor:
University Medicine Greifswald
Collaborating Sponsors:
Novartis
Conditions:
Heparin-Induced Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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).
Detailed 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 hepar...
Eligibility Criteria
Inclusion
- trauma-surgical patient
- consent given
- minimum age 18
- expected inpatient period at least 7 days
- need for thrombosis prophylaxis with heparin
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00196417
Start Date
January 1 2003
End Date
November 1 2005
Last Update
September 20 2005
Active Locations (1)
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1
Ernst-Moritz-Arndt University, Depts. of Transfusion Medicine / Trauma surgery
Greifswald, Germany, 17489