- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00673439
Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)
A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Currently, standard treatment of HIT involves the transition from a direct thrombin inhibitor (a type of anticoagulant or "blood thinner") to warfarin, a different type of anticoagulant. Direct thrombin inhibitors (DTIs) require IV administration and frequent blood draws for dose adjustments, which can lead to prolonged hospitalization. DTIs also affect blood test measurements, making it difficult to determine proper dosages of warfarin.
Fondaparinux is a drug that is approved by the FDA for the treatment of blood clots in deep veins and in the lungs. Fondaparinux is not FDA approved for the treatment of HIT. However, an increasing number of doctors are using fondaparinux instead of DTIs to treat HIT. Although fondaparinux appears to be more convenient and predictable than DTI medications, more research is needed to support its use as a treatment for HIT.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- high risk for HIT based on "Four Ts score" of 6 or more
Exclusion Criteria:
- pulmonary emboli at the time of enrollment
- arterial thrombosis at the time of enrollment
- limb threatening phlegmasia cerulea dolens at the time of enrollment
- Calculated Creatinin Clearance less than 50 ml/hr
- platelet count less than 50
- Weight less than 50 kg
- pregnancy
- allergy to fondaparinux
- bacterial endocarditis
- history of neuraxial anesthesia and post-operative indwelling epidural catheter
- active major bleeding (hemodynamically significant or requiring transfusions)
- inability to give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fondaparinux
daily subcutaneous injection of fondaparinux (7.5-10 mg)
|
Dosage form: subcutaneous injection; dosage: 7.5 to 10.0 mg; frequency and duration: daily until blood test results rule out confirmed HIT - for patients with confirmed HIT, continue daily until INR (blood clotting) measurement rises to at least 2
Other Names:
Dosage form: oral; dosage: 2.5 to 5.0 mg; frequency and duration: (for confirmed HIT only) once daily, to begin when blood platelet count reaches at least 100,000, and continue for approximately 4 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Showing Clinically Significant Bleeding
Time Frame: 4 weeks after INR reaches 2 or more
|
Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux
|
4 weeks after INR reaches 2 or more
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux
Time Frame: 4 weeks after INR reaches 2 or more
|
4 weeks after INR reaches 2 or more
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Goetz H Kloecker, MD, MSPH, James Graham Brown Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07.0100
- BCC-NON-07-001 (Other Identifier: James Graham Brown Cancer Center Clinical Trials Office)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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