Comparison of the Palindrome vs. BioFlo DuraMax Hemodialysis Catheters: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
研究概览
简要总结
Numerous catheter designs have been studied to increase efficacy and minimize complications of catheter hemodialysis. Major complications of catheters include thrombosis, central venous stenosis, infection, and dialysis inadequacy. Thrombosis must be avoided if possible because using too many catheters may exhaust all of the catheter insertion sites on the body, as well as increase the risk of infection. This prospective study compares the complications and general outcomes of patients who receive hemodialysis using the mainstream Palindrome catheter versus the newer BioFlo DuraMax catheter.
This study will examine outcomes of patients who receive hemodialysis using either the Palindrome catheter or the BioFlo catheter. Patients will be observed and outcomes will be recorded for three to six months. Outcomes will be analyzed and compared to draw conclusions on which catheter produces less catheter thrombosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Males and females 18 - 65 years of age;
- •First de novo dialysis catheter placement or second catheter exchange, no more than 3 replacements on a same site
- •Requiring at least 3 months dialysis catheter usage
- •No clinical or radiographic evidence of superior vena cava (SVC) narrowing
- •Patent right internal or external jugular vein
- •Willing to provide the dialysis center information for F/U
- •No known diagnosis of hypercoagulopathy
排除标准
- •Short term catheter usage plan (< 1 months)
- •No right jugular venous access
- •Catheter use for bone marrow transplant or plasmapheresis
结局指标
主要结局
Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
时间窗: 1 month
A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups
次要结局
- Cost Analysis(3 months)
- Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.(6 months)
研究者
Edward Wolfgang Lee, MD
MD, PhD
University of California, Los Angeles