Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)

Overview

The purpose of this study is to test the safety and efficacy of fondaparinux in patients with heparin-induced thrombocytopenia (HIT). The primary objective is to ensure that patients with HIT who are treated with fondaparinux experience a prompt and complete recovery of their platelet count, and the secondary objective is to determine if any new blood clots are formed while receiving the fondaparinux and up to one month after study enrollment. This information will be compared to a historical control.

Full Title of Study: “Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2009

Interventions

  • Drug: fondaparinux
    • fondaparinux subcutaneous injection once daily until INR stable in therapeutic range, at least five days: 5 mg if less than 50 kg, 7.5 mg if 50-100 kg, 10 mg if >100 kg
  • Drug: argatroban or lepirudin
    • continuous infusion titrated into therapeutic range and for at least 5 days and until INR stable in therapeutic range

Arms, Groups and Cohorts

  • Experimental: A
    • Fondaparinux
  • Active Comparator: B
    • Direct thrombin inhibitor

Clinical Trial Outcome Measures

Primary Measures

  • Platelet count recovery
    • Time Frame: 5 days

Secondary Measures

  • Recurrent thromboembolic complications
    • Time Frame: 4 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female at least 18 years of age; – If female of childbearing potential, negative pregnancy test result; – Diagnosis of HIT confirmed by the following: Decreased platelet count by 50% or greater OR platelets < 100,000/mm3 during or within 2 weeks after heparin exposure and/or new thromboembolic complications during or within 2 weeks after heparin exposure; – Laboratory confirmation (either heparin PF4 antibody or serotonin release assay positive). Exclusion Criteria:
  • Estimated creatinine clearance less than 30 ml/min (either measured or by using Cockcroft Gault equation); – Pregnancy or lactating; – Blood dyscrasia other than HIT; – History of thrombocytopenia associated with fondaparinux; – Recent (within 6 weeks) or planned surgery of CNS, eye or traumatic surgery resulting in large open surfaces or other procedures with high bleeding risk or if lumbar puncture is planned; – Active bleeding of GI tract, GU tract, CNS or respiratory tract; – Malignant hypertension, pericarditis, pericardial effusion, endocarditis or eclampsia; – Inadequate laboratory facilities, inadequate support system at home, alcoholism, drug abuse, psychosis or dementia; – Hypersensitivity or contraindication to warfarin or fondaparinux.
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Methodist Healthcare
    • Collaborator
      • University of Tennessee
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Bob L Lobo, Pharm.D., Principal Investigator, Methodist University Hospital
      • Sohail Minhas, MD, Principal Investigator, University of Tennessee

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