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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Hull.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Hull
ClinicalTrials.gov Identifier:
NCT01099189
First received: April 5, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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
Renal Replacement Therapy
Arteriovenous Fistula

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by University of Hull:

Primary Outcome Measures:
  • - Primary failure of access[10] - Immediate/early thrombosis or failure to mature. [ Time Frame: within 30 days of formation ] [ Designated as safety issue: No ]
    Failure to mature or thrombosis of fistula


Secondary Outcome Measures:
  • - Duplex findings of evidence of stenosis and correlation to compliance or histological findings [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • - Correlation between biomechanical compliance and histological measures of pre existing venous pathology [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • -Correlation between biomechanical compliance testing and clinical outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Assisted primary and secondary patency rates at 3 and 6 months post fistula formation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • - Functional primary patency [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

vein samples collected at time of fistula formation


Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observed cohort
All patients recruited. Observed for clinical outcomes

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patient referred for access formation

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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).
  2. Inability to give informed written consent
  3. Aged under 18 at time of referral
  4. Inability to attend follow-up appointments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099189

Contacts
Contact: George E Smith, MBBS MRCS 01482 674643 George.Smith@hey.nhs.uk
Contact: Ian C Chetter, MBChB FRCS 01482 674765 ian.chetter@hey.nhs.uk

Locations
United Kingdom
Academic Vascular Surgery Unit Not yet recruiting
Hull, Yorkshire, United Kingdom, HU3 2JZ
Principal Investigator: George E Smith, MBBS MRCS         
Sponsors and Collaborators
University of Hull
Investigators
Principal Investigator: Ian C Chetter, MBChB FRCS University of Hull
  More Information

No publications provided

Responsible Party: Ian Chetter, Academic Vascular Surgery Unit
ClinicalTrials.gov Identifier: NCT01099189     History of Changes
Other Study ID Numbers: Access 4
Study First Received: April 5, 2010
Last Updated: April 5, 2010
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Hull:
Histology
Compliance
Dialysis
Arteriovenous access fistula
vein

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Arteriovenous Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
Vascular Diseases
Vascular Fistula
Vascular Malformations

ClinicalTrials.gov processed this record on October 20, 2014