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Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)
This study is currently recruiting participants.
Verified by James Graham Brown Cancer Center, March 2008
Sponsored by: James Graham Brown Cancer Center
Information provided by: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00673439
  Purpose

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).


Condition Intervention Phase
Heparin-Induced Thrombocytopenia
Drug: fondaparinux
Drug: warfarin
Phase II

MedlinePlus related topics: Blood Thinners
Drug Information available for: Fondaparinux sodium ORG 31540 Warfarin Warfarin potassium Warfarin sodium Heparin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)

Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:
  • the incidence of clinically significant bleeding, defined as hemodynamically significant bleeding or requiring blood transfusions while being treated with fondaparinux [ Time Frame: daily monitoring ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the incidence of venous or thrombotic events after starting treatment with fondaparinux [ Time Frame: monitored daily while taking fondaparinux, weekly for 4 weeks after stopping fondaparinux ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 29
Study Start Date: November 2007
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 coerulia 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673439

Contacts
Contact: Jamie M Day, BSN 502-562-3429 jmluka01@louisville.edu

Locations
United States, Kentucky
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jamie M Day, BSN     502-562-3420     jmluka01@louisville.edu    
Principal Investigator: Goetz H Kloecker, MD, MSPH            
Sponsors and Collaborators
James Graham Brown Cancer Center
Investigators
Principal Investigator: Goetz H Kloecker, MD, MSPH James Graham Brown Cancer Center
  More Information

Responsible Party: James Graham Brown Cancer Center ( Goetz Kloecker, MD )
Study ID Numbers: 07.0100, BCC-NON-07-001
Study First Received: May 5, 2008
Last Updated: May 6, 2008
ClinicalTrials.gov Identifier: NCT00673439  
Health Authority: United States: Institutional Review Board

Keywords provided by James Graham Brown Cancer Center:
heparin-induced thrombocytopenia
thrombocytopenia
HIT
thrombosis
blood clot
blood thinner
anticoagulant
heparin
warfarin
fondaparinux
Arixtra

Study placed in the following topic categories:
Thrombocytopathy
Thrombocytopenia
Heparin-induced thrombocytopenia
Hematologic Diseases
Blood Platelet Disorders
Fondaparinux
Warfarin
Heparin
Org 31540
Thrombosis
Calcium heparin

Additional relevant MeSH terms:
Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009