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The HIT-TRAP Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Medicine Greifswald.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00196417
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00196417     History of Changes
Other Study ID Numbers: 001
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013