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NCT00444652 Clinical Trial

Thromboprophylaxis and Bariatric Surgery

Thromboembolism Clinical Trial

Official title:
Thromboprophylaxis During Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00444652
Other study ID # 3779
Secondary ID
Status Recruiting
Phase Phase 4
First received March 7, 2007
Last updated June 28, 2012
Start date November 2006
Est. completion date December 2012

Study information
Verified date June 2012
Source University Hospital, Strasbourg, France
Contact Annick Steib, MD
Phone 33 3.88.11.54.10
Email annick.steib@chru-strasbourg.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Enoxaparin
injection of enoxaparin a few time

Locations
Country Name City State
France Département d'Anesthésiologie Hôpital de Brabois Nancy Lorraine
France Laboratoire d'Hémostase Hôpital de Brabois Nancy Lorraine
France Service de Chirurgie Digestive Hôpital de Brabois Nancy Lorraine
France Service de chirurgie générale et digestive,Hôpital Hôtel Dieu Nantes
France Centre investigation Clinique Hôpital Civil Strasbourg
France Clinique de l'Orangerie Strasbourg Alsace
France Département d'Anesthésiologie Hôpital Civil 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

Sponsors (3)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France French State, Sanofi

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses 48 heures No
Secondary Microparticles day 0, 1, 9,30 No
Secondary Thrombotic events until D30 day 30 Yes
Secondary Bleeding events day 30 Yes
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