A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the Incidence of Clinically Significant Bleeding, Defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux
Study terminated, results data not available
at fondaparinux discontinuation
Goetz H Kloecker, MD, MSPH
James Graham Brown Cancer Center
United States: Institutional Review Board
|University of Louisville Hospital||Louisville, Kentucky 40202|