Thromboprophylaxis and Bariatric Surgery
Thromboprophylaxis During Bariatric Surgery
1 other identifier
interventional
300
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2006
Longer than P75 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 7, 2007
CompletedFirst Posted
Study publicly available on registry
March 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJuly 2, 2012
June 1, 2012
6 years
March 7, 2007
June 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses
48 heures
Secondary Outcomes (3)
Microparticles
day 0, 1, 9,30
Thrombotic events until D30
day 30
Bleeding events
day 30
Interventions
injection of enoxaparin a few time
Eligibility Criteria
You may qualify if:
- BMI over 40
- Gastric banding or gastric bypass
You may not qualify if:
- Renal insufficiency
- Thrombopenia
- Long term anticoagulant treatment
- Pregnancy
- Allergy to heparin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Strasbourg, Francelead
- French Statecollaborator
- Sanoficollaborator
Study Sites (10)
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
Related Publications (1)
Amaral FC, Baptista-Silva JC, Nakano LC, Flumignan RL. Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery. Cochrane Database Syst Rev. 2022 Nov 22;11(11):CD013683. doi: 10.1002/14651858.CD013683.pub2.
PMID: 36413425DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Annick Steib, MD
Hôpitaux Universitaire de Strasbourg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2007
First Posted
March 8, 2007
Study Start
November 1, 2006
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
July 2, 2012
Record last verified: 2012-06