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

NCT01099189 | Completed

• 1 other identifier: Access 4
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Replacement Therapy; Arteriovenous Fistula

Keywords

Histology; Compliance; Dialysis; Arteriovenous access fistula; vein

Outcome Measures

Primary Outcomes (1)

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

  Failure to mature or thrombosis of fistula

  within 30 days of formation

Secondary Outcomes (5)

• Duplex findings of evidence of stenosis and correlation to compliance or histological findings

  6 months

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

  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

• Functional primary patency

  6 months

Study Arms (1)

Observed cohort

All patients recruited. Observed for clinical outcomes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patient referred for access formation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• University of Hull: collaborator

Study Sites (1)

Academic Vascular Surgery Unit

Hull, Yorkshire, HU3 2JZ, United Kingdom

Location

Related Publications (1)

• Smith GE, Gohil R, Chetter IC. Factors affecting the patency of arteriovenous fistulas for dialysis access. J Vasc Surg. 2012 Mar;55(3):849-55. doi: 10.1016/j.jvs.2011.07.095. Epub 2011 Nov 8.

  PMID: 22070937 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

vein samples collected at time of fistula formation

MeSH Terms

Conditions

Arteriovenous Fistula; Patient Compliance

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ian C Chetter, MBChB FRCS

  University of Hull

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2010
• First Posted: April 6, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: July 1, 2013
• Last Updated: July 12, 2019

Record last verified: 2019-07

Locations

GB (1)