---
title: Venous Thromboprophylaxis in Bariatric Surgery
nct_id: NCT03218514
overall_status: COMPLETED
sponsor: Groupe Hospitalier Pitie-Salpetriere
study_type: OBSERVATIONAL
primary_condition: Obesity
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03218514.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03218514"
ct_last_update_post_date: 2018-10-18
last_seen_at: "2026-05-12T06:40:04.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Venous Thromboprophylaxis in Bariatric Surgery

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

**NCT ID:** [NCT03218514](https://clinicaltrials.gov/study/NCT03218514)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 118
- **Lead Sponsor:** Groupe Hospitalier Pitie-Salpetriere
- **Collaborators:** Assistance Publique Hopitaux De Marseille
- **Conditions:** Obesity
- **Start Date:** 2014-07
- **Completion Date:** 2017-07
- **CT.gov Last Update:** 2018-10-18

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Interventions

- **Dalteparin** (DRUG)

## Primary Outcomes

- **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

- **Proportion of patients with symptomatic VTE** _(time frame: 3 months)_
- **Proportion of patients with major bleeding** _(time frame: 3 months)_

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03218514.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03218514*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*