Pharmacodynamics of Fondaparinux subcutaneous versus continuous intravenous infusion in critically ill patients with or without vasopressors.

• Conditions: Thromboprophylaxis to critically ill patients hospitalized in ICU with or without vasopressors; MedDRA version: 9.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxis

• Registration Number: EUCTR2007-004911-79-BE
• Lead Sponsor: cliniques Universitaires st luc-ucl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-29
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Critically ill patient hospitalized in ICU with or without vasopressors
- Age > 18 years
- Consent obtained

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

- renal insufficiency ( Cr Clearance < 20 ml/min)
- treatment with vitamin K antagonist
- liver failure (INR > 2)
- high risk of bleeding that contraindicate anticoagulant prophylaxis (intracerebral haemorrhage, gastro- intestinal bleeding, …)
- severe thrombopenia ( < 30.000/µL)
- acute endocarditis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified