The HIT-TRAP Trial

University Medicine Greifswald

Status and phase: Unknown; Phase 4

Conditions: Heparin-Induced Thrombocytopenia

Treatments: Drug: Standard heparin (UFH) versus certoparin (LMWH)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00196417

001

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind