Venous Thromboprophylaxis in Bariatric Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03218514

Acronym

OBSUD

Enrollment

118

Registered

2017-07-14

Start date

2014-07-31

Completion date

2017-07-31

Last updated

2018-10-18

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

Conditions

Obesity

Keywords

Obesity, Venous thromboembolism, Heparin, Low-Molecular-Weight, Body Composition, Glomerular filtration rate, 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.

Interventions

DRUGDalteparin

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

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