We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196417
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by:
University Medicine Greifswald
  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
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00196417     History of Changes
Other Study ID Numbers: 001
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: December 9, 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


To Top