The Safety and Efficacy of Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism in Medical Patients With Renal Insufficiency
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 206
- Locations
- 1
- Primary Endpoint
- major bleeding
Study Overview
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 severe renal insufficiency, which is an independent risk factor for bleeding. This risk may be further increased when low molecular weight heparin or fondaparinux are administered in patients with severe renal insufficiency, defined by a creatinine clearance of lower than 30 mL/min. No clear indications are available to reduce such risk in patients who require thromboprophylaxis. A lower dose of fondaparinux, 1.5 mg daily, has been recently approved for the prevention of venous thromboembolism in the specific population of patients with a creatinine clearance between 20 and 50 mL/min (European Marketing Authorization). However, there are to our knowledge no clinical studies that have assessed the safety and efficacy of this reduced dosage in medical patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
fondaparinux
Intervention: fondaparinux (Drug)
Outcomes
Primary Outcomes
major bleeding
Time Frame: up to 48 hours from last injection
Secondary Outcomes
- symptomatic venous thromboembolism(last treatment dose)
Investigators
Walter Ageno
Associate Professor of Internal Medicine
Università degli Studi dell'Insubria