The HIT-TRAP Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Heparin-Induced Thrombocytopenia

Intervention / Treatment
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* Drug: Standard heparin (UFH) versus certoparin (LMWH)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Standard heparin (UFH) versus certoparin (LMWH)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heparin-induced thrombocytopenia, HIT, unfractionated heparin, UFH, low-molecular-weight heparin, LMWH, thrombosis prophylaxis, HIT-antibody