Fondaparinux population pharmacokinetic to morbid obese patients in post-operatory bariatric surgery

• Conditions: obese patients; MedDRA version: 12.0Level: LLTClassification code 10027966Term: Morbid obesity; MedDRA version: 12.0Level: LLTClassification code 10059610Term: Obesity surgery

• Registration Number: EUCTR2009-016417-15-FR
• Lead Sponsor: CHU de SAINT-ETIENNE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

- Age = 18 years old
- requiring a bariactric surgery
- requiring an antithrombotics prophylaxis
- having a morbid obesity based on a BMI >40 kg/m2
- having signed the inform consent form
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

- contra-indication to fondaparinux
- history of heparin induced thrombopenia (HIT)
- platelets < 100 G/l
- requiring an effective antithrombotic treatment
- aptients with justice protection

Study & Design

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