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The HIT-TRAP Trial

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ClinicalTrials.gov Identifier: NCT00196417
Recruitment Status : Unknown
Verified September 2005 by University Medicine Greifswald.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
Sponsor:
Collaborator:
Novartis
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Heparin-Induced Thrombocytopenia Drug: Standard heparin (UFH) versus certoparin (LMWH) Phase 4

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 Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : January 2003
Study Completion Date : November 2005





Primary Outcome Measures :
  1. Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients

Secondary Outcome Measures :
  1. Thromboembolic complications (TECs) during inpatient period in relation to heparin received and HIT-antibody status
  2. TECs during 3 months following discharge in relation to heparin received and HIT-antibody status


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196417


Locations
Germany
Ernst-Moritz-Arndt University, Depts. of Transfusion Medicine / Trauma surgery
Greifswald, Germany, 17489
Sponsors and Collaborators
University Medicine Greifswald
Novartis
Investigators
Principal Investigator: Andreas Greinacher, Prof. Dr. Ernst-Moritz-Arndt University Greifswald, Germany

ClinicalTrials.gov Identifier: NCT00196417     History of Changes
Other Study ID Numbers: 001
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 20, 2005
Last Verified: September 2005

Keywords provided by University Medicine Greifswald:
heparin-induced thrombocytopenia
HIT
unfractionated heparin
UFH
low-molecular-weight heparin
LMWH
thrombosis prophylaxis
HIT-antibody

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Calcium heparin
Certoparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action