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

Phase 2TerminatedNCT00673439

University of Louisville3 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heparin-Induced Thrombocytopenia

Interventions

fondaparinuxDRUG

Dosage form: subcutaneous injection; dosage: 7.5 to 10.0 mg; frequency and duration: daily until blood test results rule out confirmed HIT - for patients with confirmed HIT, continue daily until INR (blood clotting) measurement rises to at least 2

warfarinDRUG

Dosage form: oral; dosage: 2.5 to 5.0 mg; frequency and duration: (for confirmed HIT only) once daily, to begin when blood platelet count reaches at least 100,000, and continue for approximately 4 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 (1)

University of Louisville Hospital

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Number of Participants Showing Clinically Significant Bleeding

Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux

Time frame: 4 weeks after INR reaches 2 or more

Secondary Outcomes

the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux

Time frame: 4 weeks after INR reaches 2 or more

Data from ClinicalTrials.gov

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