Venous Thromboprophylaxis in Bariatric Surgery

Obesity Clinical Trial

— OBSUD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218514
• Other study ID #: CIC1421-17-07
• Status: Completed
• Start date: July 2014
• Est. completion date: July 2017

Study information

• Verified date: October 2018
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Dalteparin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere	Assistance Publique Hopitaux De Marseille

References & Publications (2)

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. 2017 Sep 21. doi: 10.1097/SLA.0000000000002536. [Epub ahead of pr — View 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. Phar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients whose peak plasma anti-Xa levels is in the prophylactic ranges	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	at least two days after thromboprophylaxis initiation
Secondary	Proportion of patients with symptomatic VTE	Proportion of patients with symptomatic VTE	3 months
Secondary	Proportion of patients with major bleeding	Proportion of patients with major bleeding	3 months