a Comparative Study of Aspirin Either at Fixed Dose or at a Dose Titrated by Platlet Function Analyzer(PFA-100) vs Placebo in Primary Prevention of Vascular Access for Hemodialysis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- number of fistula thrombosis in patients receiving a dose of aspirin titrated by the result of PFA-100 compared to placebo and fixed dose aspirin
研究概览
简要总结
This is a prospective study consisting in testing whether systematic use of aspirin is beneficial for primary prevention of vascular access for hemodialysis attested by doppler ultrasound exam. The investigators will study aspirin resistance in the population of patients undergoing hemodialysis. The investigators will test sensibility of resistant patients to aspirin dose escalation. PFA-100 is the biologic test used in this study to define aspirin resistance.
详细描述
Three groups of dialysed patients will be included in this study. The first is the placebo group, the second is the aspirin group fixed dose and the last group includes patients receiving a dose of aspirin titrated by the result of PFA-100.
At the end of this study the investigators will be able to identify whether systematic antiaggregation is suitable for a vascular access for hemodialysis. The investigators will also conclude which is better for patients fixed dose or aspirin dose escalation determined by the result of PFA-100. The study will analyse the prevalence of aspirin resistant patients in this particular population of dialysed patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •dialysed patients
- •vascular access aged less than one year
- •no serious complication of the vascular access previously such as hemorrhagic complication and tight stenosis
排除标准
- •pregnant and breastfeeding women
- •patients receiving at baseline other antiaggregant or anticoagulant
- •patient not allowed to be treated by aspirin
- •systolic blood pressure> 200 mmhg
- •diastolic blood pressure>115 mmhg
- •liver failure
研究组 & 干预措施
aspirn fixed dose
patients of this arm will receive 100 mg of aspirin daily.over the period of follow up we will detect all thromboembolic events.
干预措施: aspirin (Drug)
aspirin dose titrated with PFA-100
patients of this arm will receive 100 mg of aspirin daily.this dose will be multiplied whenever the PFA-100 is not suitable.once the time of occlusion is correct ,we will keep the same dose of aspirin and continue monitoring the PFA-100 durin the follow up period.
干预措施: aspirin (Drug)
结局指标
主要结局
number of fistula thrombosis in patients receiving a dose of aspirin titrated by the result of PFA-100 compared to placebo and fixed dose aspirin
时间窗: 1 year
patients undergoing hemodialysis via native fistula will receive either placebo or aspirin titrated dose by the PFA-100 or aspirin fixed dose to prevent thrombosis of the access .the follow up period will be fixed at 1 year and all thromboembolic complications of the access will be noted
次要结局
- number of aspirin resistant patients even to aspirin escalation dose titrated by PFA-100 in the population of dialysed patients.(1 year)
研究者
Ben Salah Manel
nephrologist
Tunis University