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

Study Overview
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Brief Summary
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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.

Official Title
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The Safety and Efficacy of Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism in Medical Patients With Renal Insufficiency

Conditions
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Medical Patients, Renal Insufficiency

Intervention / Treatment
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* Drug: fondaparinux


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fondaparinux<br> | Drug: fondaparinux<br>* once daily sc injection, 1,5 mg, max 14 days<br>* Other names: Arixtra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major bleeding |  | up to 48 hours from last injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptomatic venous thromboembolism |  | last treatment dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal failure, medical patient, venous thromboembolism, prophylaxis, fondaparinux