NCT00526123已完成不适用
A Randomized, Open-label Comparison of the Performance and Longevity of a Split-tip Versus a Symmetric Tip Hemodialysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 599
- 试验地点
- 27
- 主要终点
- First Catheter Induced Complication
研究概览
简要总结
The purpose of this clinical trial is to compare the longevity of two dialysis catheters.
详细描述
This study is a multi-center, randomized, prospective, open-label, clinical study comparing a conventional split-tip catheter and a symmetric tip catheter in subjects undergoing hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Subject must be 18 years of age or older.
- •Subject must meet labeled indication for hemodialysis.
- •Subject must have End Stage Renal Disease (ESRD).
- •Subject must have a patent right or left internal jugular vein.
- •Subject treatment plan must require chronic hemodialysis treatments 3 times per week for a minimum of 6 weeks.
- •Subject must give written informed consent.
排除标准
- •Subjects who are concurrently enrolled in any Randomized Clinical Trial (RCT) or those that may enroll in a RCT during the course of the study, or subjects who have been previously randomized into this clinical study.
- •Subjects with active infection at the time of study enrollment.
- •Subjects with a known sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
- •Subjects with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding.
- •Subjects who are known or suspected to be pregnant at the time of study enrollment or plan to get pregnant during the study period.
- •Subjects for whom performing dialysis at flow rates up to 450 mL/min would be contraindicated for any reason.
- •Subject unable or unwilling to commit to follow-up visits and study procedures throughout the course of the study.
- •Subjects who, in the opinion of the Investigators, are not appropriate candidates for the study based upon current or past medical history, or negative past experience with either of the study catheters.
结局指标
主要结局
First Catheter Induced Complication
时间窗: 245 days
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
次要结局
- Inadequate Flow Rates Requiring Surgical/Radiological Intervention(35 weeks)
- Average Number of Line Reversals Per Subject(35 Weeks)
- Frequency of Clinician Interventions for Catheter Malfunction and Infection(35 Weeks)
- Primary Failure Rate(First dialysis session with study catheter)
- Reliability of the Catheter(35 Weeks)
研究者
研究点 (27)
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