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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
University of Hull

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.

Condition or disease
Renal Replacement Therapy Arteriovenous Fistula

Study Type : Observational
Estimated Enrollment : 30 participants
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.
Study Start Date : July 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Observed cohort
All patients recruited. Observed for clinical outcomes

Primary Outcome Measures :
  1. - Primary failure of access[10] - Immediate/early thrombosis or failure to mature. [ Time Frame: within 30 days of formation ]
    Failure to mature or thrombosis of fistula

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
vein samples collected at time of fistula formation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patient referred for access formation

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01099189

Contact: George E Smith, MBBS MRCS 01482 674643
Contact: Ian C Chetter, MBChB FRCS 01482 674765

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
Principal Investigator: Ian C Chetter, MBChB FRCS University of Hull

Responsible Party: Ian Chetter, Academic Vascular Surgery Unit Identifier: NCT01099189     History of Changes
Other Study ID Numbers: Access 4
First Posted: April 6, 2010    Key Record Dates
Last Update Posted: April 6, 2010
Last Verified: March 2010

Keywords provided by University of Hull:
Arteriovenous access fistula

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