NCT02164175撤回不适用
Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Mortality
研究概览
简要总结
Data Collection Registry of the HeRO Graft for End Stage Renal Disease Patients Receiving Hemodialysis
详细描述
Data collection including medical history, operative procedure data, and follow-up data every six months while using the HeRO Graft for dialysis, including:
- Post-operative complications for HeRO Graft implantation
- Length of time between insertion and use of HeRO Graft
- Incidence of thrombosis
- Hospitalizations
- Incidence of infections and other adverse event occurrence
- Mortality
- Hemoglobin
- Kt/V
- pre-dialysis blood pressure
- post-dialysis blood pressure
- blood flow rate and
- dialysis flow rate
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •All patients eligible for HeRO Graft for dialysis access
- •Age greater than 18 years old
- •Able to give informed consent
排除标准
- •Subjects with any kind of disorder that compromises the ability of the subject to give informed consent and/or to comply with the study procedures;
- •Any medical condition that in the opinion of the investigator may pose a safety risk to a subject in the study or which may interfere with study participation.
结局指标
主要结局
Mortality
时间窗: Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years
To evaluate if the death rate of participants using the HeRO Graft is less than the death rate of patients who do not receive the HeRO Graft and continue to use a tunneled dialysis catheter for dialysis.
次要结局
- Adequacy of dialysis (Kt/V)(Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years)
- Infection rate(Every six months post-implant until death or no longer using HeRO Graft for dialysis, up to five years)
研究者
研究点 (3)
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