The HIT-TRAP Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-11-30

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.

Conditions

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Heparin-Induced Thrombocytopenia

Keywords

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heparin-induced thrombocytopenia HIT unfractionated heparin UFH low-molecular-weight heparin LMWH thrombosis prophylaxis HIT-antibody

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Standard heparin (UFH) versus certoparin (LMWH)

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Andreas Greinacher, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Ernst-Moritz-Arndt University Greifswald, Germany

Locations

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Ernst-Moritz-Arndt University, Depts. of Transfusion Medicine / Trauma surgery

Greifswald, , Germany

Site Status

Countries

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Germany

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id