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The HIT-TRAP Trial

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by University Medicine Greifswald.
Recruitment status was:  Active, not recruiting
Information provided by:
University Medicine Greifswald Identifier:
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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 Intervention Phase
Heparin-Induced Thrombocytopenia Drug: Standard heparin (UFH) versus certoparin (LMWH) Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University Medicine Greifswald:

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

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

Estimated Enrollment: 600
Study Start Date: January 2003
Estimated Study Completion Date: November 2005
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.


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00196417

Ernst-Moritz-Arndt University, Depts. of Transfusion Medicine / Trauma surgery
Greifswald, Germany, 17489
Sponsors and Collaborators
University Medicine Greifswald
Principal Investigator: Andreas Greinacher, Prof. Dr. Ernst-Moritz-Arndt University Greifswald, Germany
  More Information Identifier: NCT00196417     History of Changes
Other Study ID Numbers: 001
Study First Received: September 12, 2005
Last Updated: September 12, 2005

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

Additional relevant MeSH terms:
Blood Platelet Disorders
Hematologic Diseases
Calcium heparin
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 21, 2017