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

NCT ID: NCT01099189

Last Updated: 2019-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Replacement Therapy Arteriovenous Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observed cohort

All patients recruited. Observed for clinical outcomes

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Hull

OTHER

Sponsor Role collaborator

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ian C Chetter, MBChB FRCS

Role: PRINCIPAL_INVESTIGATOR

University of Hull

Locations

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Academic Vascular Surgery Unit

Hull, Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 22070937 (View on PubMed)

Other Identifiers

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Access 4

Identifier Type: -

Identifier Source: org_study_id

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