A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- University of Louisville
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Number of Participants Showing Clinically Significant Bleeding
Study Overview
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 Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Fondaparinux
daily subcutaneous injection of fondaparinux (7.5-10 mg)
Intervention: fondaparinux (Drug)
Fondaparinux
daily subcutaneous injection of fondaparinux (7.5-10 mg)
Intervention: warfarin (Drug)
Outcomes
Primary Outcomes
Number of Participants Showing Clinically Significant Bleeding
Time Frame: 4 weeks after INR reaches 2 or more
Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux
Secondary Outcomes
- the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux(4 weeks after INR reaches 2 or more)
Investigators
Goetz Kloecker
Associate Professor
University of Louisville