Overview

This trial is active, not recruiting.

Condition heparin-induced thrombocytopenia
Treatment standard heparin (ufh) versus certoparin (lmwh)
Phase phase 4
Sponsor University Medicine Greifswald
Collaborator Novartis
Start date January 2003
End date November 2005
Trial size 600 participants
Trial identifier NCT00196417, 001

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients
time frame:

Secondary Outcomes

Measure
Thromboembolic complications (TECs) during inpatient period in relation to heparin received and HIT-antibody status
time frame:
TECs during 3 months following discharge in relation to heparin received and HIT-antibody status
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Andreas Greinacher, Prof. Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by University Medicine Greifswald.