Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency
Status:
Terminated
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
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.