Prospective, Pharmacokinetic Study for Determination of the Relationship Between Lean Body Weight and Anti-Xa Activity 4 Hours After Subcutaneous Injection of 5700 IU Nadroparin in Morbidly Obese Patients After Bariatric Surgery.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin
研究概览
简要总结
This study is a prospective evaluation of the relationship between lean body weight and anti-Xa activity and 5700 International Units (IU) nadroparin 4 hours after subcutaneous administration in morbidly obese patients after bariatric surgery.
详细描述
There is no guideline for postoperative thromboembolic prevention in morbidly obese patients.
The investigators goal is to examine which dose of nadroparin is effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Approval for Roux-en-Y gastric bypass
- •Total body weight > 140 kg
排除标准
- •Renal impairment (GFR < 30ml/min and/ or serum creatinin > 150 micromol/ml)
- •Coagulation disorders
- •Use of vitamin K antagonists (such as acenocoumarol) pregnancy
研究组 & 干预措施
Nadroparin
patients above 140 kg will receive a dose of 2850 IU nadroparine pre-operatively, anti-Xa factor will be determined 3 days after nadroparin use. After surgery patients receive 5700 IU nadroparin (our standard treatment). Three days after surgery and 4 weeks after surgery anti-Xa factor will be measured again.
干预措施: Nadroparin (Drug)
结局指标
主要结局
anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin
时间窗: 4 hours
次要结局
未报告次要终点
研究者
Frits Berends
Dr.
Rijnstate Hospital