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

Phase 2

Terminated

• Conditions: Heparin-Induced Thrombocytopenia
• Interventions: Drug: fondaparinux; Drug: warfarin

• Registration Number: NCT00673439
• Lead Sponsor: University of Louisville

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 Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-07
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2013-05-03
• Results First Submitted QC: 2013-05-03
• Results First Posted: 2013-06-24
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-24
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• high risk for HIT based on "Four Ts score" of 6 or more

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fondaparinux	fondaparinux	daily subcutaneous injection of fondaparinux (7.5-10 mg)
Fondaparinux	warfarin	daily subcutaneous injection of fondaparinux (7.5-10 mg)

Primary Outcome Measures

Name	Time	Method
Number of Participants Showing Clinically Significant Bleeding	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 Outcome Measures

Name	Time	Method
the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux	4 weeks after INR reaches 2 or more

Trial Locations

Locations (1)

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States