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

This study has been terminated.
(study terminated due to low accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00673439
First Posted: May 7, 2008
Last Update Posted: June 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)

Resource links provided by NLM:


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: at fondaparinux discontinuation ]
    Study terminated, results data not available


Secondary Outcome Measures:
  • the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux [ Time Frame: 4 weeks after INR reaches 2 or more ]

Enrollment: 3
Study Start Date: November 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (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
    Other Name: Arixtra
    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
    Other Name: Coumadin
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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673439


Locations
United States, Kentucky
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Goetz H Kloecker, MD, MSPH James Graham Brown Cancer Center
  More Information

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00673439     History of Changes
Other Study ID Numbers: 07.0100
BCC-NON-07-001 ( Other Identifier: James Graham Brown Cancer Center Clinical Trials Office )
First Submitted: May 5, 2008
First Posted: May 7, 2008
Results First Submitted: May 3, 2013
Results First Posted: June 24, 2013
Last Update Posted: June 24, 2013
Last Verified: May 2013

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

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Calcium heparin
Fondaparinux
PENTA
Heparin
Warfarin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors