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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00927602

Enrollment

206

Registered

2009-06-25

Start date

2009-04-30

Completion date

2012-03-31

Last updated

2012-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Patients, Renal Insufficiency

Keywords

renal failure, medical patient, venous thromboembolism, prophylaxis, fondaparinux

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.

Interventions

DRUGfondaparinux

once daily sc injection, 1,5 mg, max 14 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
major bleeding	up to 48 hours from last injection

Secondary

Measure	Time frame
symptomatic venous thromboembolism	last treatment dose

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026