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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Heparin-Induced Thrombocytopenia

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the Incidence of Clinically Significant Bleeding, Defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux

Outcome Description:

Study terminated, results data not available

Outcome Time Frame:

at fondaparinux discontinuation

Safety Issue:

Yes

Principal Investigator

Goetz H Kloecker, MD, MSPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

07.0100

NCT ID:

NCT00673439

Start Date:

November 2007

Completion Date:

September 2011

Related Keywords:

  • Heparin-Induced Thrombocytopenia
  • heparin-induced thrombocytopenia
  • thrombocytopenia
  • HIT
  • thrombosis
  • blood clot
  • blood thinner
  • anticoagulant
  • heparin
  • warfarin
  • fondaparinux
  • Arixtra
  • Thrombocytopenia

Name

Location
University of Louisville Hospital Louisville, Kentucky  40202