SOLACEA-H vs HYDROLINK-NVU for Haemodialysis Sessions in Extracorporeal Circulation Heparin-sparing Situations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- SOLACEA-H vs HYDROLINK-NVU efficacy
研究概览
简要总结
The aim of the study is to evaluate the efficacy of the SOLACEA-H dialyser, particularly in patients at high risk of haemorrhage, during post-dilution haemodiafiltration sessions with complete or partial heparin sparing. It will be compared with another dialyser (HYDROLINK-NVU)
详细描述
This is a randomised, crossover, open-label, prospective, multicentre post-marketing clinical follow-up study comparing two medical devices used (SOLACEA-H dialyser vs HYDROLINK-NVU dialyser) for their intended purpose.
Each patient will be followed for approximately 2 months, depending on the number of sessions in the anticoagulant reduction phase.
Patients will be offered the study by the investigator during a dialysis session as part of routine practice. If the patient accepts and signs the informed consent form, he or she will receive a succession of dialysis sessions including first the SOLACEA-H then the HYDROLINK-NVU membrane, or vice versa, depending on randomisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •On haemodialysis for at least 3 months
- •Dialysis in a haemodialysis department of the Ramsay-Santé group
- •No active infection
- •Medically stable
- •Blood flow ≥ 300 ml/min
- •Haemoglobin level stable and within recommended norms for a dialysis patient, id est > 10g/dl
- •Bipunction
- •No known allergy to SOLACEA H or HYDROLINK-NVU
- •Willingness to comply with study procedures for the duration of the study
- •For women of childbearing age: effective contraception, or absence of active pregnancy (negative pregnancy test)
- •Member or beneficiary of a social security scheme
- •Patient having been informed and having signed an informed consent form
排除标准
- •Patient on oral anticoagulants for the duration of the study
- •Patient on dialysate for the duration of the study
- •Patient Medically unstable or fragile
- •Severe hepatic impairment
- •Patient hospitalised without consent
- •Concurrent participation in another clinical study
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- •Pregnant, breast-feeding or parturient women
- •Patient unable to receive heparin
- •Known allergy to latex or phthalates
研究组 & 干预措施
A : SOLACEA-H/HYDROLINK-NVU
The dialysis sessions will take place in the following order :
Wash - SOLACEA-H dialysis - Wash - HYDROLINK-NVU dialysis
干预措施: SOLACEA-H/HYDROLINK-NVU (Device)
B : HYDROLINK-NVU/SOLACEA-H
The dialysis sessions will take place in the following order :
Wash - HYDROLINK-NVU dialysis - Wash - SOLACEA-H dialysis
干预措施: HYDROLINK-NVU/SOLACEA-H (Device)
结局指标
主要结局
SOLACEA-H vs HYDROLINK-NVU efficacy
时间窗: 2 month
The primary endpoint is dialysis time, as a marker of a complete and successful dialysis session. This criterion will make it possible to evaluate the effectiveness of a dialysis treatment with SOLACEA-H, complete without total coagulation of the circuit with little or no anticoagulant , with a similar or lesser quantity than that used for the current treatment with HYDROLINK-NVU.
次要结局
未报告次要终点