Clinical Trial: Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)

Brief 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).

Detailed Summary:

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.


Sponsor: James Graham Brown Cancer Center

Current Primary Outcome: 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 ]

Study terminated, results data not available


Original Primary Outcome: the Incidence of Clinically Significant Bleeding, Defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux [ Time Frame: daily monitoring ]

Current Secondary Outcome: the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux [ Time Frame: 4 weeks after INR reaches 2 or more ]

Original Secondary Outcome: the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux [ Time Frame: monitored daily while taking fondaparinux, weekly for 4 weeks after stopping fondaparinux ]

Information By: James Graham Brown Cancer Center

Dates:
Date Received: May 5, 2008
Date Started: November 2007
Date Completion:
Last Updated: May 3, 2013
Last Verified: May 2013