Heparin-Induced Thrombocytopenia Clinical Trial
Official title:
A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)
Verified date | October 2019 |
Source | University of Louisville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Louisville Hospital | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
University of Louisville | James Graham Brown Cancer Center |
United States,
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 |
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