Thromboprophylaxis and Bariatric Surgery

Phase 4

• Conditions: Thromboembolism

• Registration Number: NCT00444652
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types of bariatric surgery.

- gastric banding and gastric bypass on anti-Xa activity levels

The study includes two groups of 150 patients scheduled for gastric banding or gastric bypass.

Assessment of anti-Xa levels before and 4 hours after the injections from day 0 to 2 in order to determine the best prophylactic regimen allowing expected values ranged between 0.3 and 0.5 IU / ml.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-03-07
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-08
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-28
• Last Update Posted: 2012-07-02
• Primary Completion: 2012-11
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• BMI over 40
• Gastric banding or gastric bypass

Exclusion Criteria

• Renal insufficiency
• Thrombopenia
• Long term anticoagulant treatment
• Pregnancy
• Allergy to heparin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses	48 heures

Secondary Outcome Measures

Name	Time	Method
Microparticles	day 0, 1, 9,30
Thrombotic events until D30	day 30
Bleeding events	day 30

Trial Locations

Locations (10)

Département d'Anesthésiologie Hôpital Civil; 🇫🇷 Strasbourg, Alsace, France

Clinique de l'Orangerie; 🇫🇷 Strasbourg, Alsace, France

Laboratoire d'hémostase Hôpital de Hautepierre; 🇫🇷 Strasbourg, Alsace, France

Service de Chirurgie Digestive Hopital de Hautepierre; 🇫🇷 Strasbourg, Alsace, France

Service de Chirurgie Générale et Endocrinienne Hôpital Civil; 🇫🇷 Strasbourg, Alsace, France

Service de chirurgie générale et digestive,Hôpital Hôtel Dieu; 🇫🇷 Nantes, France

Service de Chirurgie Digestive Hôpital de Brabois; 🇫🇷 Nancy, Lorraine, France

Centre investigation Clinique Hôpital Civil; 🇫🇷 Strasbourg, France

Département d'Anesthésiologie Hôpital de Brabois; 🇫🇷 Nancy, Lorraine, France

Laboratoire d'Hémostase Hôpital de Brabois; 🇫🇷 Nancy, Lorraine, France