Evaluating Body Size Descriptors on Peak Anti-Xa Levels in Bariatric Surgery Obese Patients Receiving Low Molecular Weight Heparin Fixed Doses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 主要终点
- Proportion of patients whose peak plasma anti-Xa levels is in the prophylactic ranges
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •anticoagulant administration within 48 hours preceding surgery
- •on-going antiplatelet therapy
- •pregnancy
结局指标
主要结局
Proportion of patients whose peak plasma anti-Xa levels is in the prophylactic ranges
时间窗: 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
次要结局
- Proportion of patients with major bleeding(3 months)
- Proportion of patients with symptomatic VTE(3 months)
研究者
Joe Elie Salem
MD, PhD
Groupe Hospitalier Pitie-Salpetriere