Back to resultsThe HIT-TRAP Trial
Primary Purpose
Heparin-Induced Thrombocytopenia
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Standard heparin (UFH) versus certoparin (LMWH)
Sponsored by
About this trial
This is an interventional treatment trial for Heparin-Induced Thrombocytopenia focused on measuring heparin-induced thrombocytopenia, HIT, unfractionated heparin, UFH, low-molecular-weight heparin, LMWH, thrombosis prophylaxis, HIT-antibody
Eligibility 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
Sites / Locations
- Ernst-Moritz-Arndt University, Depts. of Transfusion Medicine / Trauma surgery
Outcomes
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
Full Information
NCT ID
NCT00196417
First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
University Medicine Greifswald
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00196417
Brief Title
The HIT-TRAP Trial
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 Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Medicine Greifswald
Collaborators
Novartis
4. Oversight
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heparin-Induced Thrombocytopenia
Keywords
heparin-induced thrombocytopenia, HIT, unfractionated heparin, UFH, low-molecular-weight heparin, LMWH, thrombosis prophylaxis, HIT-antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Standard heparin (UFH) versus certoparin (LMWH)
Primary Outcome Measure Information:
Title
Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients
Secondary Outcome Measure Information:
Title
Thromboembolic complications (TECs) during inpatient period in relation to heparin received and HIT-antibody status
Title
TECs during 3 months following discharge in relation to heparin received and HIT-antibody status
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Greinacher, Prof. Dr.
Organizational Affiliation
Ernst-Moritz-Arndt University Greifswald, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ernst-Moritz-Arndt University, Depts. of Transfusion Medicine / Trauma surgery
City
Greifswald
ZIP/Postal Code
17489
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
The HIT-TRAP Trial
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