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Clinical Trials/EUCTR2008-005234-79-IT
EUCTR2008-005234-79-ITActive, not recruitingNot Applicable

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

DIPARTIMENTO DI MEDICINA CLINICA - UNIVERSITA` DEGLI STUDI DELL`INSUBRIA0 sitesStarted: November 19, 2008Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

  • . 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

Investigators

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

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