OBSUD: Venous Thromboprophylaxis in Bariatric Surgery

Sponsor

Groupe Hospitalier Pitie-Salpetriere (Other)

Overall Status

Completed

CT.gov ID

NCT03218514

Collaborator

Assistance Publique Hopitaux De Marseille (Other)

118

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

The main aim of this study is to compare the influence of total body-weight (TBW), lean body-weight (LBW), ideal body-weight (IBW) or Body Mass Index (BMI) on peak anti-Xa levels at steady-state in bariatric surgery (BS) morbidly obese patients receiving a fixed double dose of dalteparin (5000 IU subcutaneously, twice daily a day) for venous thromboembolism (VTE) prevention. Secondary aims of this study are to identify which body size descriptors (BSD) has the greatest impact and could further be explored for an adjusted low molecular weight heparin (LMWH) dosing algorithm for achieving optimal VTE prevention in BS severely obese patients.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Dalteparin

Detailed Description

Severely obese patients undergoing bariatric surgery (BS) are at increased risk for venous thromboembolism (VTE). How standard LMWH regimen should be adapted to provide both sufficient efficacy and safety in this setting is unclear. The aim of this study is to compare the influence of four BSD on peak anti-Xa levels in BS obese patients receiving high LMWH fixed doses to identify which one had the greatest impact and could further be proposed in LMWH-based thromboprophylaxis dosing algorithms.

Study Design

Study Type:

Observational

Actual Enrollment :

118 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluating Body Size Descriptors on Peak Anti-Xa Levels in Bariatric Surgery Obese Patients Receiving Low Molecular Weight Heparin Fixed Doses

Actual Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Outcome Measures

Primary Outcome Measures

Proportion of patients whose peak plasma anti-Xa levels is in the prophylactic ranges [at least two days after thromboprophylaxis initiation]
Proportion of patients whose peak plasma anti-Xa levels is in the prophylactic ranges.The target range for prophylactic anti-Xa levels is defined as 0.2 to 0.5 IU/ml

Secondary Outcome Measures

Proportion of patients with symptomatic VTE [3 months]
Proportion of patients with symptomatic VTE
Proportion of patients with major bleeding [3 months]
Proportion of patients with major bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

between 18 and 70 years old
BMI ≥ 40 Kg/m² or BMI ≥ 35 Kg/m² with at least one or more obesity-related co-morbidities ( including type II diabetes (T2DM), hypertension, obstructive sleep apnea (OSA), non-alcoholic fatty liver disease, severe osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease)
scheduled for sleeve gastrectomy (SG) or gastric bypass procedure (GBP)
informed consent

Exclusion Criteria:

anticoagulant administration within 48 hours preceding surgery
on-going antiplatelet therapy
pregnancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Groupe Hospitalier Pitie-Salpetriere
Assistance Publique Hopitaux De Marseille

Investigators

Principal Investigator: Benedicte Gaborit, Inserm U1062, Inra U1260, Aix Marseille Université, Faculté de Médecine, Assistance Publique - Hôpitaux de Marseille