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ObesityOBSUDNCT03218514

Venous Thromboprophylaxis in Bariatric Surgery

An observational study of Obesity, run by Groupe Hospitalier Pitie-Salpetriere.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Obesity
What is being tested?
Dalteparin
How many people
118 participants
Where
No sites listed yet
Study dates
Jul 2014to Jul 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Obese patients undergoing bariatric surgery

Who may be able to join

  • 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

Who cannot join

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

About this study

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

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.

Read the 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.

Conditions
Obesity
Being tested
Dalteparin
Keywords
Obesity, Venous thromboembolism, Heparin, Low-Molecular-Weight, Body Composition, Glomerular filtration rate, Bariatric Surgery
Medical subject headings
Obesity, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DalteparinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at least two days after thromboprophylaxis initiation

Secondary outcomes (2)

  1. Proportion of patients with symptomatic VTE

    Proportion of patients with symptomatic VTE

    Measured: 3 months

  2. Proportion of patients with major bleeding

    Proportion of patients with major bleeding

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2017
  2. Study startJul 2014
  3. Primary completionMar 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03218514
Sponsor's protocol ID
CIC1421-17-07
Acronym
OBSUD
Status last verified
Oct 2018
First submitted
10 Jul 2017
Last updated
18 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No

Publications

  • 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.

    PubMed 28938272

  • 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.

    PubMed 29452290

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Groupe Hospitalier Pitie-Salpetriere.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients whose peak plasma anti-Xa levels is in the prophylactic ranges (time frame: at least two days after thromboprophylaxis initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03218514, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.

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