NCT03218514

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

2.7 years

First QC Date

July 10, 2017

Last Update Submit

October 17, 2018

Conditions

Obesity

Keywords

ObesityVenous thromboembolismHeparin, Low-Molecular-WeightBody CompositionGlomerular filtration rateBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Proportion of patients with symptomatic VTE

    3 months

  • Proportion of patients with major bleeding

    3 months

Interventions

DalteparinDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obese patients undergoing bariatric surgery

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. 2018 Dec;268(6):e51-e52. doi: 10.1097/SLA.0000000000002536. No abstract available.

    PMID: 28938272RESULT

  • 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.

    PMID: 29452290RESULT

MeSH Terms

Conditions

ObesityVenous Thromboembolism

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Benedicte Gaborit

    Inserm U1062, Inra U1260, Aix Marseille Université, Faculté de Médecine, Assistance Publique - Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 14, 2017

Study Start

July 1, 2014

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

October 18, 2018

Record last verified: 2018-10