Status:
TERMINATED
Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
James Graham Brown Cancer Center
Conditions:
Heparin-Induced Thrombocytopenia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 thromb...
Eligibility Criteria
Inclusion
- high risk for HIT based on "Four Ts score" of 6 or more
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00673439
Start Date
November 1 2007
End Date
September 1 2011
Last Update
November 8 2019
Active Locations (1)
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1
University of Louisville Hospital
Louisville, Kentucky, United States, 40202