Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)
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).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)|
- the incidence of clinically significant bleeding, defined as hemodynamically significant bleeding or requiring blood transfusions while being treated with fondaparinux [ Time Frame: at fondaparinux discontinuation ] [ Designated as safety issue: Yes ]
- the incidence of venous or thrombotic events after starting treatment with fondaparinux [ Time Frame: 4 weeks after INR reaches 2 or more ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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.
|United States, Kentucky|
|University of Louisville Hospital|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Goetz H Kloecker, MD, MSPH||James Graham Brown Cancer Center|