Safety and efficacy of fondaparinux 1.5 mg in the prevention of venous thromboembolism in medical patients with severe renal insufficiency - ND
- Conditions
- Hospitalized medical patients with moderate to severe renal insufficiency and indication to the use of pharmacological antithrombotic prophylaxis
- Registration Number
- EUCTR2008-005234-79-IT
- Lead Sponsor
- DIPARTIMENTO DI MEDICINA CLINICA - UNIVERSITA` DEGLI STUDI DELL`INSUBRIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
.Age > 60 years. Hospitalization for one of the following diseases: heart failure NYHA class III/IV, acute respiratory insufficiency, acute infection or acute inflammatory diseases (arthritis, connective tissue diseases or inflammatory bowel diseases) .at least four days of hospitalization . Renal insufficiency defined by a creatinine clearance between 20 and 50 ml/min calculated using the MDRD formula .written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
. Active Hemorrhage or in the previous three months .known hemorrhagic diathesis .platelet count < than 100.000 .Active treatment with unfractionated heparin, low molecular weight heparin or fondaparinux at therapeutic dosage or treatment with oral anticoagulant therapy. Previous administration of prophylactic doses of unfractionated heparin, low molecular weight heparin or fondaparinux from more than 48 hours .Life expectation < 1 month
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Main objective of the study is to evaluate the safety of a reduced dosage of fondaparinux for the prevention of venous thromboembolism in hospitalized medical patients with moderate/severe renal insufficiency;Secondary Objective: Main objective of the study is to evaluate the efficacy of a reduced dosage of fondaparinux for the prevention of venous thromboembolism in hospitalized medical patients with moderate/severe renal insufficiency;Primary end point(s): Incidence of major bleeding up to 48 hours after the last study drug administration
- Secondary Outcome Measures
Name Time Method