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Safety and efficacy of fondaparinux 1.5 mg in the prevention of venous thromboembolism in medical patients with severe renal insufficiency - ND

Safety and efficacy of fondaparinux 1.5 mg in the prevention of venous thromboembolism in medical patients with severe renal insufficiency - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-005234-79-IT
Enrollment
Unknown
Registered
2008-11-19
Start date
2009-05-07
Completion date
Unknown
Last updated
2012-09-03

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

Conditions

Hospitalized medical patients with moderate to severe renal insufficiency and indication to the use of pharmacological antithrombotic prophylaxis

Interventions

Trade Name: ARIXTRA*SC 7SIR 1,5MG 0,3ML Pharmaceutical Form: Solution for injection INN or Proposed INN: Fondaparinux Concentration unit: mg milligram(s) Concentration type: equal Concentration number

Sponsors

DIPARTIMENTO DI MEDICINA CLINICA - UNIVERSITA` DEGLI STUDI DELL`INSUBRIA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: .Age > 60 years. Hospitalization for one of the following diseases: heart failure NYHA class III/IV, acute respiratory insufficiency, acute infection or acute inflammatory diseases (arthritis, connective tissue diseases or inflammatory bowel diseases) .at least four days of hospitalization . Renal insufficiency defined by a creatinine clearance between 20 and 50 ml/min calculated using the MDRD formula .written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: . Active Hemorrhage or in the previous three months .known hemorrhagic diathesis .platelet count < than 100.000 .Active treatment with unfractionated heparin, low molecular weight heparin or fondaparinux at therapeutic dosage or treatment with oral anticoagulant therapy. Previous administration of prophylactic doses of unfractionated heparin, low molecular weight heparin or fondaparinux from more than 48 hours .Life expectation < 1 month

Design outcomes

Primary

MeasureTime frame
Main Objective: Main objective of the study is to evaluate the safety of a reduced dosage of fondaparinux for the prevention of venous thromboembolism in hospitalized medical patients with moderate/severe renal insufficiency;Secondary Objective: Main objective of the study is to evaluate the efficacy of a reduced dosage of fondaparinux for the prevention of venous thromboembolism in hospitalized medical patients with moderate/severe renal insufficiency;Primary end point(s): Incidence of major bleeding up to 48 hours after the last study drug administration—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026