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Thromboprophylaxis and Bariatric Surgery

Primary Purpose

Thromboembolism

Status

Unknown status

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Enoxaparin

About this trial

This is an interventional prevention trial for Thromboembolism focused on measuring Thromboprophylaxis, Bariatric surgery, prevention of venous thromboembolism in bariatric surgery

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

BMI over 40
Gastric banding or gastric bypass

Exclusion Criteria:

Renal insufficiency
Thrombopenia
Long term anticoagulant treatment
Pregnancy
Allergy to heparin

Sites / Locations

Clinique de l'OrangerieRecruiting
Département d'Anesthésiologie Hôpital CivilRecruiting
Laboratoire d'hémostase Hôpital de HautepierreRecruiting
Service de Chirurgie Digestive Hopital de HautepierreRecruiting
Service de Chirurgie Générale et Endocrinienne Hôpital CivilRecruiting
Département d'Anesthésiologie Hôpital de BraboisRecruiting
Laboratoire d'Hémostase Hôpital de BraboisRecruiting
Service de Chirurgie Digestive Hôpital de BraboisRecruiting
Service de chirurgie générale et digestive,Hôpital Hôtel DieuRecruiting
Centre investigation Clinique Hôpital CivilRecruiting

Outcomes

Primary Outcome Measures

Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses

Secondary Outcome Measures

Microparticles

Thrombotic events until D30

Bleeding events

Full Information

NCT ID

NCT00444652

First Posted

March 7, 2007

Last Updated

June 28, 2012

Sponsor

University Hospital, Strasbourg, France

Collaborators

French State, Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00444652

Brief Title

Thromboprophylaxis and Bariatric Surgery

Official Title

Thromboprophylaxis During Bariatric Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

November 2006 (undefined)

Primary Completion Date

November 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Strasbourg, France

Collaborators

French State, Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thromboembolism

Keywords

Thromboprophylaxis, Bariatric surgery, prevention of venous thromboembolism in bariatric surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Enoxaparin

Intervention Description

injection of enoxaparin a few time

Primary Outcome Measure Information:

Title

Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses

Time Frame

48 heures

Secondary Outcome Measure Information:

Title

Microparticles

Time Frame

day 0, 1, 9,30

Title

Thrombotic events until D30

Time Frame

day 30

Title

Bleeding events

Time Frame

day 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: BMI over 40 Gastric banding or gastric bypass Exclusion Criteria: Renal insufficiency Thrombopenia Long term anticoagulant treatment Pregnancy Allergy to heparin

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Annick Steib, MD

Phone

33 3.88.11.54.10

annick.steib@chru-strasbourg.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annick Steib, MD

Organizational Affiliation

Hôpitaux Universitaire de Strasbourg

Official's Role

Study Director

Facility Information:

Facility Name

Clinique de l'Orangerie

City

Strasbourg

State/Province

Alsace

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bernard Vailly, MD

Phone

33 388567300

BVAILLY@aol.com

First Name & Middle Initial & Last Name & Degree

Philippe Plobner, MD

First Name & Middle Initial & Last Name & Degree

Bernard Vailly, MD

Facility Name

Département d'Anesthésiologie Hôpital Civil

City

Strasbourg

State/Province

Alsace

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martine Figier, MD

Phone

33 388117354

martine.figier@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Martine Figier, MD

Facility Name

Laboratoire d'hémostase Hôpital de Hautepierre

City

Strasbourg

State/Province

Alsace

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lelia Grunebaum, MD

Phone

3 3388127528

lelia.grunebaum@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Lelia Grunebaum, MD

Facility Name

Service de Chirurgie Digestive Hopital de Hautepierre

City

Strasbourg

State/Province

Alsace

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Serge Rohr, MD

Phone

33 388127223

serge.rohr@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Elisabeth Ackermann, MD

First Name & Middle Initial & Last Name & Degree

Serge Rohr, MD

Facility Name

Service de Chirurgie Générale et Endocrinienne Hôpital Civil

City

Strasbourg

State/Province

Alsace

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michel Vix, MD

Phone

33 388116883

michel.vix@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Michel Vix, MD

First Name & Middle Initial & Last Name & Degree

Jacques Marescaux, MD

Facility Name

Département d'Anesthésiologie Hôpital de Brabois

City

Nancy

State/Province

Lorraine

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Etienne Junke, MD

Phone

33 612163929

e.junke@chu-nancy.fr

First Name & Middle Initial & Last Name & Degree

Etienne Junke, MD

First Name & Middle Initial & Last Name & Degree

Claude Meistelman, MD

Facility Name

Laboratoire d'Hémostase Hôpital de Brabois

City

Nancy

State/Province

Lorraine

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Lecompte, MD

Phone

33 383851015

thomas.lecompte@chu-nancy.fr

First Name & Middle Initial & Last Name & Degree

Thomas Lecompte, MD

Facility Name

Service de Chirurgie Digestive Hôpital de Brabois

City

Nancy

State/Province

Lorraine

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurent Brunaud, MD

Phone

33 3 83858585

i.brunaud@chu-nancy.fr

First Name & Middle Initial & Last Name & Degree

Laurent Brunaud, MD

Facility Name

Service de chirurgie générale et digestive,Hôpital Hôtel Dieu

City

Nantes

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

karim Asehnoune, MD

Phone

00 332 40.08.30.05

karim.asehnoune@chu-nantes.fr

First Name & Middle Initial & Last Name & Degree

Karim Asehnoune, MD

First Name & Middle Initial & Last Name & Degree

Bertrand Rozec, MD

First Name & Middle Initial & Last Name & Degree

Eric Letessier, MD

First Name & Middle Initial & Last Name & Degree

Salvatore Avalonne, MD

Facility Name

Centre investigation Clinique Hôpital Civil

City

Strasbourg

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascal Bousquet, MD

Phone

33 3881176768

pascal.bousquet@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Pascal Bousquet, MD

First Name & Middle Initial & Last Name & Degree

Brandt Christian, MD

First Name & Middle Initial & Last Name & Degree

Dominique Charneau, MD

12. IPD Sharing Statement

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Thromboprophylaxis and Bariatric Surgery

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