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Study 10 of 168 for search of: | "Thrombocytopenia" |
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Sponsored by: |
James Graham Brown Cancer Center |
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Information provided by: | James Graham Brown Cancer Center |
ClinicalTrials.gov Identifier: | NCT00673439 |
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 |
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) |
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) |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jamie M Day, BSN | 502-562-3429 | jmluka01@louisville.edu |
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 |
Principal Investigator: | Goetz H Kloecker, MD, MSPH | James Graham Brown Cancer Center |
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 |
heparin-induced thrombocytopenia thrombocytopenia HIT thrombosis blood clot blood thinner |
anticoagulant heparin warfarin fondaparinux Arixtra |
Thrombocytopathy Thrombocytopenia Heparin-induced thrombocytopenia Hematologic Diseases Blood Platelet Disorders Fondaparinux |
Warfarin Heparin Org 31540 Thrombosis Calcium heparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |