Vein Histology in Arteriovenous Fistulas and Its Effect on Fistula Surgery Success
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.
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.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Yorkshire
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Hull、Yorkshire、英国、HU3 2JZ
- Academic Vascular Surgery Unit
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
|
Observed cohort
All patients recruited.
Observed for clinical outcomes
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Primary failure of access - Immediate/early thrombosis or failure to mature.
大体时间:within 30 days of formation
|
Failure to mature or thrombosis of fistula
|
within 30 days of formation
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Duplex findings of evidence of stenosis and correlation to compliance or histological findings
大体时间:6 months
|
6 months
|
|
Correlation between biomechanical compliance and histological measures of pre existing venous pathology
大体时间:6 months
|
6 months
|
|
Correlation between biomechanical compliance testing and clinical outcomes
大体时间:6 months
|
6 months
|
|
Assisted primary and secondary patency rates at 3 and 6 months post fistula formation
大体时间:6 months
|
6 months
|
|
Functional primary patency
大体时间:6 months
|
6 months
|
合作者和调查者
调查人员
- 首席研究员:Ian C Chetter, MBChB FRCS、University of Hull
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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