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

University of Louisville (UOFL)

Status and phase: Terminated; Phase 2

Conditions: Heparin-Induced Thrombocytopenia

Treatments: Drug: warfarin; Drug: fondaparinux

Study type: Interventional

Funder types: Other

Identifiers

NCT00673439

BCC-NON-07-001 (Other Identifier)

07.0100

Details and patient eligibility

About

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).

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Fondaparinux

Experimental group

Description:

daily subcutaneous injection of fondaparinux (7.5-10 mg)

Treatment:

Drug: warfarin

Drug: fondaparinux