HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 12
- 主要终点
- Clotting of the dialysis session
研究概览
简要总结
The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the heparin free treatment can be performed easily (without saline flushes or blood predilution) and is at least not inferior and maybe superior to the standard care heparin free treatment in terms of clotting.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring heparin free dialysis treatments on nephrologists' prescription,
- •Chronic ESRD patients treated by maintenance hemodialysis for at least 3 months,
- •Patients with a well functioning blood access that can allow a blood flow of at least 250 ml/min,
- •Patients aged 18 years or more,
- •Written consent to participate in the study (informed consent).
排除标准
- •Patients in ICU settings,
- •AKI patients,
- •Patients dialyzed in self care, satellite HD units,
- •Patients treated in single needle mode,
- •Known heparin contraindication (HIT type II),
- •Patients requiring blood and other labile blood products (i.e. fresh frozen plasma, platelets, etc …) transfusion during hemodialysis treatment,
- •Patients receiving oral anticoagulants (including Anti vitamin K),
- •Patients receiving a combination of anti-platelets agents,
- •Patients treated with unfractionated or low molecular weight heparin beside the dialysis treatment to prevent deep vein thrombosis,
- •Pregnant/ planning pregnancy and lactating women during study period,
- •Adult patients protected by the law,
- •Patients are not affiliated to health insurance system (beneficiary or dependant)
- •Participation in other interventional studies during the study period,
- •Patients that have already been included in this study.
结局指标
主要结局
Clotting of the dialysis session
时间窗: During first dialysis session_Dialysis duration: 4 hours
To evaluate the rate of successful treatments, clotting in the air traps will be evaluated using a scale grading from 1 to 4 and previously described in the literature. The first heparin free dialysis treatment will be considered successful when there is: * No complete occlusion of air traps or dialyzer rendering dialysis impossible (grade 4 of the scale), * No additional saline flushes to prevent clotting, * No change of dialyzer or blood lines because of clotting * No premature stop (early rinse-back) because of clotting
次要结局
- Clotting during consecutive dialysis session(2nd and 3rd consecutive dialysis sessions)
- Follow up of clotting during the dialysis sessions(During all dialysis sessions)
- Efficacy: Ultrafiltration(During all dialysis sessions)
- Ease of use(During all dialysis sessions)
- Incidence of AEs/SAEs(During all dialysis sessions)