Vein Histology in Arteriovenous Fistulas and Its Effect on Fistula Surgery Success
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|ClinicalTrials.gov Identifier: NCT01099189|
Recruitment Status : Unknown
Verified March 2010 by University of Hull.
Recruitment status was: Not yet recruiting
First Posted : April 6, 2010
Last Update Posted : April 6, 2010
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.
|Condition or disease|
|Renal Replacement Therapy Arteriovenous Fistula|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||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.|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||March 2011|
|Estimated Study Completion Date :||September 2011|
All patients recruited. Observed for clinical outcomes
- - Primary failure of access - Immediate/early thrombosis or failure to mature. [ Time Frame: within 30 days of formation ]Failure to mature or thrombosis of fistula
- - Duplex findings of evidence of stenosis and correlation to compliance or histological findings [ Time Frame: 6 months ]
- - Correlation between biomechanical compliance and histological measures of pre existing venous pathology [ Time Frame: 6 months ]
- -Correlation between biomechanical compliance testing and clinical outcomes [ Time Frame: 6 months ]
- Assisted primary and secondary patency rates at 3 and 6 months post fistula formation [ Time Frame: 6 months ]
- - Functional primary patency [ Time Frame: 6 months ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099189
|Contact: George E Smith, MBBS MRCS||01482 674643||George.Smith@hey.nhs.uk|
|Contact: Ian C Chetter, MBChB FRCS||01482 email@example.com|
|Academic Vascular Surgery Unit||Not yet recruiting|
|Hull, Yorkshire, United Kingdom, HU3 2JZ|
|Principal Investigator: George E Smith, MBBS MRCS|
|Principal Investigator:||Ian C Chetter, MBChB FRCS||University of Hull|