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Thromboprophylaxis and Bariatric Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Adult)
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

Locations
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, 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
Sponsors and Collaborators
University Hospital, Strasbourg, France
French State
Sanofi
Investigators
Study Director: Annick Steib, MD Hôpitaux Universitaire de Strasbourg
  More Information

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
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 09, 2016