Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)
Information source: James Graham Brown Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heparin-Induced Thrombocytopenia
Intervention: fondaparinux (Drug); warfarin (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: James Graham Brown Cancer Center Official(s) and/or principal investigator(s): Goetz H Kloecker, MD, MSPH, Principal Investigator, Affiliation: James Graham Brown Cancer Center
Summary
The purpose of this study is to determine how safe and effective fondaparinux is in treating
patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).
Clinical Details
Official title: A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: the Incidence of Clinically Significant Bleeding, Defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux
Secondary outcome: the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Louisville Hospital, Louisville, Kentucky 40202, United States
Additional Information
Starting date: November 2007
Last updated: May 3, 2013
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