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
French State
Information provided by (Responsible Party):
University Hospital, Strasbourg, France Identifier:
First received: March 7, 2007
Last updated: June 28, 2012
Last verified: June 2012

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
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

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

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 identifier: NCT00444652

Contact: Annick Steib, MD 33

Laboratoire d'hémostase Hôpital de Hautepierre Recruiting
Strasbourg, Alsace, France
Contact: Lelia Grunebaum, MD    3 3388127528   
Sub-Investigator: Lelia Grunebaum, MD         
Département d'Anesthésiologie Hôpital Civil Recruiting
Strasbourg, Alsace, France
Contact: Martine Figier, MD    33 388117354   
Sub-Investigator: Martine Figier, MD         
Service de Chirurgie Digestive Hopital de Hautepierre Recruiting
Strasbourg, Alsace, France
Contact: Serge Rohr, MD    33 388127223   
Sub-Investigator: Elisabeth Ackermann, MD         
Principal Investigator: Serge Rohr, MD         
Service de Chirurgie Générale et Endocrinienne Hôpital Civil Recruiting
Strasbourg, Alsace, France
Contact: Michel Vix, MD    33 388116883   
Principal Investigator: Michel Vix, MD         
Sub-Investigator: Jacques Marescaux, MD         
Clinique de l'Orangerie Recruiting
Strasbourg, Alsace, France
Contact: Bernard Vailly, MD    33 388567300   
Sub-Investigator: Philippe Plobner, MD         
Principal Investigator: Bernard Vailly, MD         
Département d'Anesthésiologie Hôpital de Brabois Recruiting
Nancy, Lorraine, France
Contact: Etienne Junke, MD    33 612163929   
Principal Investigator: Etienne Junke, MD         
Sub-Investigator: Claude Meistelman, MD         
Laboratoire d'Hémostase Hôpital de Brabois Recruiting
Nancy, Lorraine, France
Contact: Thomas Lecompte, MD    33 383851015   
Sub-Investigator: Thomas Lecompte, MD         
Service de Chirurgie Digestive Hôpital de Brabois Recruiting
Nancy, Lorraine, France
Contact: Laurent Brunaud, MD    33 3 83858585   
Principal Investigator: Laurent Brunaud, MD         
Service de chirurgie générale et digestive,Hôpital Hôtel Dieu Recruiting
Nantes, France
Contact: karim Asehnoune, MD    00 332   
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   
Principal Investigator: Pascal Bousquet, MD         
Sub-Investigator: Brandt Christian, MD         
Sub-Investigator: Dominique Charneau, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
French State
Study Director: Annick Steib, MD Hôpitaux Universitaire de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France 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:
Bariatric surgery
prevention of venous thromboembolism in bariatric surgery

Additional relevant MeSH terms:
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases processed this record on November 30, 2015