Thromboprophylaxis and Bariatric Surgery

Thromboprophylaxis During Bariatric Surgery

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00444652

Enrollment

300

Registered

2007-03-08

Start date

2006-11-30

Completion date

2012-12-31

Last updated

2012-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolism

Keywords

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

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.

Interventions

DRUGEnoxaparin

injection of enoxaparin a few time

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses	48 heures

Secondary

Measure	Time frame
Microparticles	day 0, 1, 9,30
Thrombotic events until D30	day 30
Bleeding events	day 30

Countries

France

Contacts

Primary ContactAnnick Steib, MD

annick.steib@chru-strasbourg.fr33 3.88.11.54.10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026