Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The occurrence, or not, of a success of the dialytic technique.
研究概览
简要总结
This research is based on the hypothesis that the Hydrolink®-NV dialysis membrane could allow the realization of quality dialysis with a significant reduction in the doses of Orgaran®, or even a total cessation of the anticoagulant, in patients with chronic renal failure. with heparin-induced thrombocytopenia.
Thus, this study aims to show that the use of this dialysis membrane without prior anticoagulation does not increase the risk of coagulation of the circuit and allows the realization of quality dialysis sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patient, male or female, over 18 years of age.
- •Patient on dialysis in a hemodialysis unit of the Ramsay Santé group.
- •Patient with diagnosed heparin induced thrombocytopenia.
- •Patient whose dialysis sessions benefit from extracorporeal circulation anticoagulation with Orgaran® or its equivalent (Arixtra® or Arganova®).
- •Patient informed and having signed his written consent to participate in the study.
- •Affiliated patient or beneficiary of a social security scheme.
- •Woman of childbearing age with effective contraception, after verification of the absence of active pregnancy (negative pregnancy test)
排除标准
- •Patient whose duration of dialysis is less than 1 month.
- •Medically unstable or fragile patient.
- •Patient participating in another clinical study.
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
- •Pregnant, breastfeeding or parturient women.
- •Patient hospitalized without consent.
- •Patient with severe hepatic failure
研究组 & 干预措施
end-stage renal disease patients with heparin-induced thrombocytopenia
The research procedure consists of dialysing patients on a Hydrolink-NV® membrane with an anticoagulant dose decrease protocol. This protocol of decrease is done over a period of about 6 months divided into 4 periods.
干预措施: Hydrolink NV membrane (Procedure)
结局指标
主要结局
The occurrence, or not, of a success of the dialytic technique.
时间窗: 7 months
The success of the dialytic technique is defined as the reduction, over the whole of period 4 of the study, of at least 50% of the dose of Orgaran® received by the patient at each dialysis session, compared to to that administered in period 2 of the study.
次要结局
未报告次要终点