Clinical trial NCT03218514: Venous Thromboprophylaxis in Bariatric Surgery
Official title: Evaluating Body Size Descriptors on Peak Anti-Xa Levels in Bariatric Surgery Obese Patients Receiving Low Molecular Weight Heparin Fixed Doses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Venous thromboembolism
Heparin, Low-Molecular-Weight
Body Composition
Glomerular filtration rate
Bariatric Surgery
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Assistance Publique Hopitaux De Marseille
First posted: 2017-07-14
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients undergoing bariatric surgery

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients whose peak plasma anti-Xa levels is in the prophylactic ranges
timeFrame: at least two days after thromboprophylaxis initiation
Secondary outcomes:
measure: Proportion of patients with symptomatic VTE
timeFrame: 3 months
measure: Proportion of patients with major bleeding
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Inserm U1062, Inra U1260, Aix Marseille Université, Faculté de Médecine, Assistance Publique - Hôpitaux de Marseille
name: Benedicte Gaborit
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaborit B, Aron-Wisnewsky J, Salem JE, Bege T, Frere C. Pharmacologic Venous Thromboprophylaxis After Bariatric Surgery: Burning Questions Regarding Doses, Duration, and Strategy. Ann Surg. 2018 Dec;268(6):e51-e52. doi: 10.1097/SLA.0000000000002536. No abstract available.
citation: Gaborit B, Moulin PA, Bege T, Boullu S, Vincentelli C, Emungania O, Morange PE, Berdah S, Salem JE, Dutour A, Frere C. Lean body weight is the best scale for venous thromboprophylaxis algorithm in severely obese patients undergoing bariatric surgery. Pharmacol Res. 2018 May;131:211-217. doi: 10.1016/j.phrs.2018.02.012. Epub 2018 Feb 13.