NCT01181544已完成不适用
Heparin Dose Reduction During Hemodialysis With the Gambro Revaclear and Revaclear MAX Hemodialyzers: Pilot Study I and II
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in dialyzer blood compartment volume when the heparin dose is adjusted using a Robbins-Monro algorithm
研究概览
简要总结
During hemodialysis treatments, patients receive heparin to prevent clotting. The purpose of this pilot study is to determine if the amount of heparin administered during a patient's hemodialysis can be individualized using an equation for heparin dose adjustment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years of age or older
- •Stable hemodialysis prescription prior to study enrollment
- •Dialyzing through a native fistula or Gore-Tex graft
- •Blood access must be able to provide a blood flow rate of 400 ml/min
排除标准
- •Non-compliance with dialysis
- •Hematocrit less than 28%
- •Active Infection
- •Diagnosis of Heparin-Induced Thrombocytopenia (HIT)
结局指标
主要结局
Change in dialyzer blood compartment volume when the heparin dose is adjusted using a Robbins-Monro algorithm
时间窗: up to 8 weeks
The objective is to titrate each patient's heparin dose to the level that achieves adequate anticoagulation for that patient as assessed by the change in blood compartment volume of the dialyzer from pre- to post-dialysis. The strategy that will be used is the Robbins-Monro stochastic approximation algorithm.
次要结局
- Evaluation of dialyzer performance and visual assessment of clotting in the fiber bundle and the arterial and venous headers(up to 8 weeks)
研究者
研究点 (2)
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