The HIT-TRAP Trial

Heparin-Induced Thrombocytopenia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00196417
• Other study ID #: 001
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: January 2003
• Est. completion date: November 2005

Study information

• Verified date: September 2005
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heparin-Induced Thrombocytopenia
• Thrombocytopenia
• Thrombocytosis

Intervention

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

Locations

Country	Name	City	State
Germany	Ernst-Moritz-Arndt University, Depts. of Transfusion Medicine / Trauma surgery	Greifswald

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients
Secondary	Thromboembolic complications (TECs) during inpatient period in relation to heparin received and HIT-antibody status
Secondary	TECs during 3 months following discharge in relation to heparin received and HIT-antibody status