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

Phase 4

Terminated

• Conditions: Medical Patients; Renal Insufficiency
• Interventions: Drug: fondaparinux

• Registration Number: NCT00927602
• Lead Sponsor: Università degli Studi dell'Insubria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-06-24
• Study First Submitted QC: 2009-06-24
• Study First Posted: 2009-06-25
• Primary Completion: 2011-12
• Study Completion: 2012-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-23
• Last Update Posted: 2012-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 206

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fondaparinux	fondaparinux	-

Primary Outcome Measures

Name	Time	Method
major bleeding	up to 48 hours from last injection

Secondary Outcome Measures

Name	Time	Method
symptomatic venous thromboembolism	last treatment dose

Trial Locations

Locations (1)

University Of Insubria; 🇮🇹 Varese, Italy