Post Marketing Surveillance Investigating Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- Clearance for urea, phosphate, beta-2-microglobulin blood cell drop, complement factor C5a, TAT
研究概览
简要总结
The aim of the dialyzer evaluation is to compare performance characteristics and haemocompatibility of the Baxter Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux dialyzers
详细描述
The Xenium+ is a new high flux dialyzer made from Polynephron membrane designed and manufactured by the Nipro Company in Japan. This dialyzer has been subjected to in-vitro testing, and all legally required biological safety tests have been conducted and CE-mark was granted in June 2010. Xenium+ has the same Polynephron membrane as the Xenium family of dialyzers which has been available commercially globally for approximately three years. Clinical evaluations have been completed with the Polynephron membrane within the last three years. The improvement in the Xenium+ line is that the casing is now made from polypropylene.
The aim of the dialyzer evaluation is to compare performance characteristics and hemocompatibility of the Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux dialyzers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ESRD patients 18 years or older
- •Stable on hemodialysis for more than 3 months
- •An average haematocrit value of 30 % or higher in the last three 3 months
- •Stable vascular access of either a fistula or graft
- •Stable anticoagulation and regimen
- •Stable erythropoiesis-stimulating agent (ESA) regimen for the last three 3 months
- •No active infection
- •Able to sign informed consent and able to participate in the study
- •Medically stable
排除标准
- •Participation in another study which may interfere with the planned study
- •Active infection
- •Medical conditions which may interfere with the study (cardiac, liver disease, hepatitis)
- •Female(s) who are pregnant or planning to be pregnant
- •Problem with or allergy to anticoagulation
- •Central venous catheters
结局指标
主要结局
Clearance for urea, phosphate, beta-2-microglobulin blood cell drop, complement factor C5a, TAT
时间窗: January 2011
次要结局
- General survey of the dialysis treatments(January 2011)