Thromboprophylaxis and Bariatric Surgery

University Hospital, Strasbourg, France300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

300

Conditions

Thromboembolism

Interventions

EnoxaparinDRUG

injection of enoxaparin a few time

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (10)

Clinique de l'Orangerie

Strasbourg, Alsace, France

RECRUITING

Département d'Anesthésiologie Hôpital Civil

Strasbourg, Alsace, France

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 48 heures

Secondary Outcomes

Microparticles

Time frame: day 0, 1, 9,30

Thrombotic events until D30

Time frame: day 30

Bleeding events

Time frame: day 30

Central Contacts

Annick Steib, MD

CONTACT

33 3.88.11.54.10 annick.steib@chru-strasbourg.fr

Data from ClinicalTrials.gov

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