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临床试验/NCT01099189
NCT01099189已完成不适用

A Cohort Study of the Histopathological Changes Evident in Vein Wall at the Time of Arteriovenous Dialysis Access Fistulas and the Effects of Such Changes on Biomechanical Compliance and Patient's Clinical Outcomes in a University Teaching Hospital.

Hull University Teaching Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Primary failure of access - Immediate/early thrombosis or failure to mature.

研究概览

简要总结

Patients whose kidneys have failed need to receive dialysis treatment, most commonly with a dialysis machine. In order to be connected to the machine an operation is often performed to join an artery to a vein in the arm. This forms what is known as an arteriovenous fistula. The fistula causes an increase in the flow of blood through the vein and the vein reacts to this by becoming bigger and thicker, making it easier to connect the patient to the machine.

The success rate for the operation is relatively low and only approximately 65 from every 100 operations is still working after a year. It is thought that one factor that may cause problems with the fistula is the ability of the vein to stretch in response to increased blood flow. Previous research has shown that veins in kidney failure patients look different to those of people whose kidneys are working when viewed under a microscope.

The investigators aim to study the structure of the vein that is used in making fistulas with a microscope and also to test it in an engineering laboratory to see how much it will stretch. The investigators hope that gaining information about the structure of the vein and its ability to stretch will help determine what it is about the vein that affects how well it works as part of a fistula. This information may help surgeons select the best possible vein in a given patient to give the best chance of a working fistula in the future.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Patients referred to vascular consultants for AV fistula formation for haemodialysis access.
  • Ability to give informed written consent
  • Aged over 18 at time of referral

排除标准

  • Veins identified on preoperative ultrasound scanning to be of a calibre too small to allow sufficient material to be obtained for biomechanical testing (<3mm diameter).
  • Inability to give informed written consent
  • Aged under 18 at time of referral
  • Inability to attend follow-up appointments

结局指标

主要结局

Primary failure of access - Immediate/early thrombosis or failure to mature.

时间窗: within 30 days of formation

Failure to mature or thrombosis of fistula

次要结局

  • Correlation between biomechanical compliance and histological measures of pre existing venous pathology(6 months)
  • Duplex findings of evidence of stenosis and correlation to compliance or histological findings(6 months)
  • Functional primary patency(6 months)
  • Correlation between biomechanical compliance testing and clinical outcomes(6 months)
  • Assisted primary and secondary patency rates at 3 and 6 months post fistula formation(6 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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