Thromboprophylaxis and Bariatric Surgery

June 28, 2012 updated by: University Hospital, Strasbourg, France

Thromboprophylaxis During Bariatric Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • Recruiting
        • Service de chirurgie générale et digestive,Hôpital Hôtel Dieu
        • Contact:
        • Principal Investigator:
          • Karim Asehnoune, MD
        • Sub-Investigator:
          • Bertrand Rozec, MD
        • Sub-Investigator:
          • Eric Letessier, MD
        • Sub-Investigator:
          • Salvatore Avalonne, MD
      • Strasbourg, France
        • Recruiting
        • Centre investigation Clinique Hôpital Civil
        • Contact:
        • Principal Investigator:
          • Pascal Bousquet, MD
        • Sub-Investigator:
          • Brandt Christian, MD
        • Sub-Investigator:
          • Dominique Charneau, MD
    • Alsace
      • Strasbourg, Alsace, France
        • Recruiting
        • Clinique de l'Orangerie
        • Contact:
        • Sub-Investigator:
          • Philippe Plobner, MD
        • Principal Investigator:
          • Bernard Vailly, MD
      • Strasbourg, Alsace, France
        • Recruiting
        • Département d'Anesthésiologie Hôpital Civil
        • Contact:
        • Sub-Investigator:
          • Martine Figier, MD
      • Strasbourg, Alsace, France
        • Recruiting
        • Laboratoire d'hémostase Hôpital de Hautepierre
        • Contact:
        • Sub-Investigator:
          • Lelia Grunebaum, MD
      • Strasbourg, Alsace, France
        • Recruiting
        • Service de Chirurgie Digestive Hopital de Hautepierre
        • Contact:
        • Sub-Investigator:
          • Elisabeth Ackermann, MD
        • Principal Investigator:
          • Serge Rohr, MD
      • Strasbourg, Alsace, France
        • Recruiting
        • Service de Chirurgie Générale et Endocrinienne Hôpital Civil
        • Sub-Investigator:
          • Jacques Marescaux, MD
        • Contact:
    • Lorraine
      • Nancy, Lorraine, France
        • Recruiting
        • Département d'Anesthésiologie Hôpital de Brabois
        • Contact:
        • Principal Investigator:
          • Etienne Junke, MD
        • Sub-Investigator:
          • Claude Meistelman, MD
      • Nancy, Lorraine, France
        • Recruiting
        • Laboratoire d'Hémostase Hôpital de Brabois
        • Contact:
        • Sub-Investigator:
          • Thomas Lecompte, MD
      • Nancy, Lorraine, France
        • Recruiting
        • Service de Chirurgie Digestive Hôpital de Brabois
        • Contact:
        • Principal Investigator:
          • Laurent Brunaud, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI over 40
  • Gastric banding or gastric bypass

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses
Time Frame: 48 heures
48 heures

Secondary Outcome Measures

Outcome Measure
Time Frame
Microparticles
Time Frame: day 0, 1, 9,30
day 0, 1, 9,30
Thrombotic events until D30
Time Frame: day 30
day 30
Bleeding events
Time Frame: day 30
day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Collaborators

Sanofi
French State

Investigators

  • Study Director: Annick Steib, MD, Hôpitaux Universitaire de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 8, 2007

Study Record Updates

Last Update Posted (Estimate)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 28, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3779

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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