Thromboprophylaxis and Bariatric Surgery

This study is currently recruiting participants.

Verified June 2012 by University Hospital, Strasbourg, France

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

History of Changes

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:

MedlinePlus related topics: Weight Loss Surgery

Drug Information available for: Enoxaparin sodium

U.S. FDA Resources

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:

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

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
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 Civil	Recruiting
Strasbourg, Alsace, France
Contact: Martine Figier, MD 33 388117354 martine.figier@chru-strasbourg.fr
Sub-Investigator: Martine Figier, 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
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
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
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Enoxaparin
Anticoagulants

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013

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