The HIT-TRAP Trial

Phase 4

• Conditions: Heparin-Induced Thrombocytopenia

• Registration Number: NCT00196417
• Lead Sponsor: University Medicine Greifswald

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 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 Timeline

• Study Start: 2003-01
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Last Update Submitted: 2005-09-12
• Study First Posted: 2005-09-20
• Last Update Posted: 2005-09-20
• Study Completion: 2005-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ernst-Moritz-Arndt University, Depts. of Transfusion Medicine / Trauma surgery; 🇩🇪 Greifswald, Germany