CClinicalTrials.gg
Sign In
Status unknownNCT00444652Updated Jul 2, 2012

Thromboprophylaxis and Bariatric Surgery

A Phase 4 interventional study of Enoxaparin in Thromboembolism, sponsored by University Hospital, Strasbourg, France. Status unknown at 10 sites in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-07-02.

Sponsored by University Hospital, Strasbourg, France · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Thromboembolism

Browse trials for

Keywords

  • Thromboprophylaxis
  • Bariatric surgery
  • prevention of venous thromboembolism in bariatric surgery
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's planned enrollment of 300 is above the median of 196 across 436 interventional studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • BMI over 40
  • Gastric banding or gastric bypass

Exclusion criteria

Exclusion Criteria:

  • Renal insufficiency
  • Thrombopenia
  • Long term anticoagulant treatment
  • Pregnancy
  • Allergy to heparin
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Interventions

  • DrugEnoxaparin

    injection of enoxaparin a few time

06

What researchers measure

Primary outcomes

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

    Time frame: 48 heures

Secondary outcomes

  1. Microparticles

    Time frame: day 0, 1, 9,30

  2. Thrombotic events until D30

    Time frame: day 30

  3. Bleeding events

    Time frame: day 30

07

Study locations

10 of 10 sites recruiting
  • Clinique de l'Orangerie
    Strasbourg, Alsace, France
    • Bernard Vailly, MD · Contact · BVAILLY@aol.com · 33 388567300
    • Philippe Plobner, MD · Sub investigator
    • Bernard Vailly, MD · Principal investigator
    Recruiting
  • Département d'Anesthésiologie Hôpital Civil
    Strasbourg, Alsace, France
    Recruiting
  • Laboratoire d'hémostase Hôpital de Hautepierre
    Strasbourg, Alsace, France
    Recruiting
  • Service de Chirurgie Digestive Hopital de Hautepierre
    Strasbourg, Alsace, France
    • Serge Rohr, MD · Contact · serge.rohr@chru-strasbourg.fr · 33 388127223
    • Elisabeth Ackermann, MD · Sub investigator
    • Serge Rohr, MD · Principal investigator
    Recruiting
  • Service de Chirurgie Générale et Endocrinienne Hôpital Civil
    Strasbourg, Alsace, France
    • Michel Vix, MD · Contact · michel.vix@chru-strasbourg.fr · 33 388116883
    • Michel Vix, MD · Principal investigator
    • Jacques Marescaux, MD · Sub investigator
    Recruiting
  • Département d'Anesthésiologie Hôpital de Brabois
    Nancy, Lorraine, France
    • Etienne Junke, MD · Contact · e.junke@chu-nancy.fr · 33 612163929
    • Etienne Junke, MD · Principal investigator
    • Claude Meistelman, MD · Sub investigator
    Recruiting
  • Laboratoire d'Hémostase Hôpital de Brabois
    Nancy, Lorraine, France
    Recruiting
  • Service de Chirurgie Digestive Hôpital de Brabois
    Nancy, Lorraine, France
    • Laurent Brunaud, MD · Contact · i.brunaud@chu-nancy.fr · 33 3 83858585
    • Laurent Brunaud, MD · Principal investigator
    Recruiting
  • Service de chirurgie générale et digestive,Hôpital Hôtel Dieu
    Nantes, France
    • karim Asehnoune, MD · Contact · karim.asehnoune@chu-nantes.fr · 00 332 40.08.30.05
    • Karim Asehnoune, MD · Principal investigator
    • Bertrand Rozec, MD · Sub investigator
    • Eric Letessier, MD · Sub investigator
    • Salvatore Avalonne, MD · Sub investigator
    Recruiting
  • Centre investigation Clinique Hôpital Civil
    Strasbourg, France
    • Pascal Bousquet, MD · Contact · pascal.bousquet@chru-strasbourg.fr · 33 3881176768
    • Pascal Bousquet, MD · Principal investigator
    • Brandt Christian, MD · Sub investigator
    • Dominique Charneau, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00444652
Lead sponsor
University Hospital, Strasbourg, France
Collaborators
French State, Sanofi
Responsible party
Sponsor
First posted
Mar 8, 2007
Start date
Nov 2006
Primary completion
Nov 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Jul 2, 2012

Study contacts

Annick Steib, MD
Contact
annick.steib@chru-strasbourg.fr
33 3.88.11.54.10
Annick Steib, MD
study director · Hôpitaux Universitaire de Strasbourg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Thromboembolism→

Other studies from this sponsor

University Hospital, Strasbourg, France

Start the discussion