Status:
TERMINATED
Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency
Lead Sponsor:
Università degli Studi dell'Insubria
Conditions:
Medical Patients
Renal Insufficiency
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
Fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous thromboembolism in high risk medical patients. A relevant proportion of medical patients have moderate to s...
Eligibility Criteria
Inclusion
- Age \> 60 years
- Acute medical disease requiring thromboprophylaxis according to international guidelines
- Anticipated immobilization of at least 4 days
- Renal insufficiency defined by creatinine clearance between 20 and 50 mL/min according the MDRD formula
- Written informed consent
Exclusion
- Active bleeding or bleeding in the previous 3 months
- Known bleeding diathesis
- Platelet count \< 100.000
- Ongoing treatment with unfractionated heparin, low molecular weight heparin, fondaparinux, or vitamin K antagonists
- Use of prophylactic doses of heparin, low molecular weight heparin, or fondaparinux in the previous 72 hours
- Life expectancy \< 1 month
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT00927602
Start Date
April 1 2009
End Date
March 1 2012
Last Update
April 24 2012
Active Locations (1)
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1
University Of Insubria
Varese, Italy, 21100