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

Heparin-Induced Thrombocytopenia Clinical Trial

Official title:

A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00673439
• Other study ID #: 07.0100
• Secondary ID: BCC-NON-07-001
• Status: Terminated
• Phase: Phase 2
• Start date: November 2007
• Est. completion date: September 2011

Study information

• Verified date: October 2019
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heparin-Induced Thrombocytopenia
• Thrombocytopenia

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
United States	University of Louisville Hospital	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	James Graham Brown Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Showing Clinically Significant Bleeding	Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux	4 weeks after INR reaches 2 or more
Secondary	the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux		4 weeks after INR reaches 2 or more