Thromboprophylaxis and Bariatric Surgery

University Hospital, Strasbourg, France

Status and phase: Unknown; Phase 4

Conditions: Thromboembolism

Treatments: Drug: Enoxaparin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00444652

3779

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)