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NCT Number: NCT03218514

Venous Thromboprophylaxis in Bariatric Surgery

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Embolism and Thrombosis Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dalteparin

Drug

Primary outcomes

  1. Proportion of patients whose peak plasma anti-Xa levels is in the prophylactic ranges

    Time frame: 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 outcomes

  1. Proportion of patients with symptomatic VTE

    Time frame: 3 months

    Proportion of patients with symptomatic VTE

  2. Proportion of patients with major bleeding

    Time frame: 3 months

    Proportion of patients with major bleeding

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Collaborators

  • Assistance Publique Hopitaux De Marseille

Registry information

Official study title

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

Acronym: OBSUD

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2017
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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