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

NCT ID: NCT00673439

Last Updated: 2019-11-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2011-09-30

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.

Conditions

Heparin-Induced Thrombocytopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fondaparinux

daily subcutaneous injection of fondaparinux (7.5-10 mg)

Group Type: EXPERIMENTAL

fondaparinux

Intervention Type: DRUG

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

warfarin

Intervention Type: DRUG

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

Interventions

fondaparinux

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

Intervention Type: DRUG

warfarin

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

Intervention Type: DRUG

Other Intervention Names

Arixtra; Coumadin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James Graham Brown Cancer Center

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Goetz Kloecker

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Goetz H Kloecker, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

James Graham Brown Cancer Center

Locations

University of Louisville Hospital

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

BCC-NON-07-001

Identifier Type: OTHER

Identifier Source: secondary_id

07.0100

Identifier Type: -

Identifier Source: org_study_id