Thromboprophylaxis and Bariatric Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
French State
Sanofi
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00444652
First received: March 7, 2007
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Thromboembolism
Drug: Enoxaparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Thromboprophylaxis During Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses [ Time Frame: 48 heures ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Microparticles [ Time Frame: day 0, 1, 9,30 ] [ Designated as safety issue: No ]
  • Thrombotic events until D30 [ Time Frame: day 30 ] [ Designated as safety issue: Yes ]
  • Bleeding events [ Time Frame: day 30 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: November 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Enoxaparin
    injection of enoxaparin a few time
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI over 40
  • Gastric banding or gastric bypass

Exclusion Criteria:

  • Renal insufficiency
  • Thrombopenia
  • Long term anticoagulant treatment
  • Pregnancy
  • Allergy to heparin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444652

Contacts
Contact: Annick Steib, MD 33 3.88.11.54.10 annick.steib@chru-strasbourg.fr

Locations
France
Service de Chirurgie Digestive Hopital de Hautepierre Recruiting
Strasbourg, Alsace, France
Contact: Serge Rohr, MD    33 388127223    serge.rohr@chru-strasbourg.fr   
Sub-Investigator: Elisabeth Ackermann, MD         
Principal Investigator: Serge Rohr, MD         
Clinique de l'Orangerie Recruiting
Strasbourg, Alsace, France
Contact: Bernard Vailly, MD    33 388567300    BVAILLY@aol.com   
Sub-Investigator: Philippe Plobner, MD         
Principal Investigator: Bernard Vailly, MD         
Département d'Anesthésiologie Hôpital Civil Recruiting
Strasbourg, Alsace, France
Contact: Martine Figier, MD    33 388117354    martine.figier@chru-strasbourg.fr   
Sub-Investigator: Martine Figier, MD         
Service de Chirurgie Générale et Endocrinienne Hôpital Civil Recruiting
Strasbourg, Alsace, France
Contact: Michel Vix, MD    33 388116883    michel.vix@chru-strasbourg.fr   
Principal Investigator: Michel Vix, MD         
Sub-Investigator: Jacques Marescaux, MD         
Laboratoire d'hémostase Hôpital de Hautepierre Recruiting
Strasbourg, Alsace, France
Contact: Lelia Grunebaum, MD    3 3388127528    lelia.grunebaum@chru-strasbourg.fr   
Sub-Investigator: Lelia Grunebaum, MD         
Département d'Anesthésiologie Hôpital de Brabois Recruiting
Nancy, Lorraine, France
Contact: Etienne Junke, MD    33 612163929    e.junke@chu-nancy.fr   
Principal Investigator: Etienne Junke, MD         
Sub-Investigator: Claude Meistelman, MD         
Service de Chirurgie Digestive Hôpital de Brabois Recruiting
Nancy, Lorraine, France
Contact: Laurent Brunaud, MD    33 3 83858585    i.brunaud@chu-nancy.fr   
Principal Investigator: Laurent Brunaud, MD         
Laboratoire d'Hémostase Hôpital de Brabois Recruiting
Nancy, Lorraine, France
Contact: Thomas Lecompte, MD    33 383851015    thomas.lecompte@chu-nancy.fr   
Sub-Investigator: Thomas Lecompte, MD         
Service de chirurgie générale et digestive,Hôpital Hôtel Dieu Recruiting
Nantes, France
Contact: karim Asehnoune, MD    00 332 40.08.30.05    karim.asehnoune@chu-nantes.fr   
Principal Investigator: Karim Asehnoune, MD         
Sub-Investigator: Bertrand Rozec, MD         
Sub-Investigator: Eric Letessier, MD         
Sub-Investigator: Salvatore Avalonne, MD         
Centre investigation Clinique Hôpital Civil Recruiting
Strasbourg, France
Contact: Pascal Bousquet, MD    33 3881176768    pascal.bousquet@chru-strasbourg.fr   
Principal Investigator: Pascal Bousquet, MD         
Sub-Investigator: Brandt Christian, MD         
Sub-Investigator: Dominique Charneau, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
French State
Sanofi
Investigators
Study Director: Annick Steib, MD Hôpitaux Universitaire de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00444652     History of Changes
Other Study ID Numbers: 3779
Study First Received: March 7, 2007
Last Updated: June 28, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Thromboprophylaxis
Bariatric surgery
prevention of venous thromboembolism in bariatric surgery

Additional relevant MeSH terms:
Thromboembolism
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014