NCT00444652Unknown4 期
Thromboprophylaxis During Bariatric Surgery
University Hospital, Strasbourg, France10 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses
研究概览
简要总结
This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types of bariatric surgery.
- gastric banding and gastric bypass on anti-Xa activity levels
The study includes two groups of 150 patients scheduled for gastric banding or gastric bypass.
Assessment of anti-Xa levels before and 4 hours after the injections from day 0 to 2 in order to determine the best prophylactic regimen allowing expected values ranged between 0.3 and 0.5 IU / ml.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI over 40
- •Gastric banding or gastric bypass
排除标准
- •Renal insufficiency
- •Thrombopenia
- •Long term anticoagulant treatment
- •Pregnancy
- •Allergy to heparin
结局指标
主要结局
Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses
时间窗: 48 heures
次要结局
- Microparticles(day 0, 1, 9,30)
- Thrombotic events until D30(day 30)
- Bleeding events(day 30)
研究者
研究点 (10)
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