Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency

Università degli Studi dell'Insubria

Status and phase

Terminated

Phase 4

Conditions

Medical Patients

Renal Insufficiency

Treatments

Drug: fondaparinux

Study type

Interventional

Funder types

Other

Identifiers

NCT00927602

2008-005234-79

Details and patient eligibility

About

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.

Enrollment

206 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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