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Completed

NCT Number: NCT01099189

Vein Histology in Arteriovenous Fistulas and Its Effect on Fistula Surgery Success

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Duplex findings of evidence of stenosis and correlation to compliance or histological findings

    Time frame: 6 months

  2. Correlation between biomechanical compliance and histological measures of pre existing venous pathology

    Time frame: 6 months

  3. Correlation between biomechanical compliance testing and clinical outcomes

    Time frame: 6 months

  4. Assisted primary and secondary patency rates at 3 and 6 months post fistula formation

    Time frame: 6 months

  5. Functional primary patency

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Collaborators

  • University of Hull

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Apr 6, 2010
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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