Validation of Arterio Venous Access Stage (AVAS) Classification (VAVASC)

March 27, 2024 updated by: Vascular surgery, University hospital Královské Vinohrady, Prague

Validation of Arterio Venous Access Stage Classification by Using Machine Learning in Prediction of Vascular Access Creation and Uninterrupted Use of the Vascular Access for Dialysis

VAVASC trial is an observational multicentre study. The aim of this trial is to validate AVAS (arteriovenous vascular access stage) classification. The classification is used for determining which type of access is the most suitable for the patient on the basis of the patient´s vascular anatomy

The methodology of this trial is to apply AVAS classification on patients who are indicated for creation of vascular access for hemodialysis. Data on these patients (vascular anatomy status, AVAS type, and predicted type of arterio venous access, demographic data etc.) will be than statistically analysed. Patients will then undergo creation of the selected arteriovenous access. They will be observed in terms of the access functionality. The follow up will be 1 to 3 years. The second aim of this study is to evaluate the relationship between AVAS classification and uninterrupted use of the created arterio venous access.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Ultrasound of upper limb vessels as a part of preoperative assessment of patients referred for arteriovenous access placement has been recommended repeatedly in several studies and guidelines. Each patient needing arterio-venous access (AVA) is unique and has different possibilities for fistula creation that depend on many factors as well the anatomical condition of inflow arteries and outflow veins, the so-called 'arteriovenous access map'. In 2020 we created, published and retrospectively evaluated the inter-rater reliability of the AVAS classification, which is a simplified way of sharing the information about suitability for access creation depending on vascular anatomy (doi: 10.1093/ckj/sfaa189).

However, before routine use of the AVAS classification system in clinical practise it requires prospective validation and comparison with other clinical factors. Finally, whether the AVAS classification can be used for the prediction of vascular access function as defined by uninterrupted use of vascular access for dialysis without need for any access intervention/procedures (SONG-HD, doi: 10.1053/j.ajkd.2017.12.003) remains to be tested.

This project has two main parts:

  1. Validation of AVAS classification with and without combination with other factors using a predictive statistical model

    .

  2. Validation of AVAS classification in terms of prediction of uninterrupted use of successfully created vascular access for dialysis.

The data will be collected prospectively. Both parts of the project will be taking place simultaneously.

Data will be collected prospectively (Belfast City Hospital, UK, University hospital Královské Vinohrady Prague CZ). Other centres around the world will be asked for cooperation (announcement will be posted via Twitter, ResearchGate, LinkedIn, Facebook and Kidney Academy) in January 2021. The data collected will be the parameters of the vessels on the upper limb, in order to be able to evaluate AVAS (VAVASC FORM). Along with anatomical dispositions of the patients, other parameters will be collected.

Obligatory parameters (parameters A):

Side of the arm (Left / Right) Dominant hand (Left / Right) Allen's test (Positive / Negative) (A negative Allen's test is demonstration of a complete palmar arch and intact collateral blood flow to the hand) Sex(M / F) Age, Height, Weight, BMI, Diabetes (Yes / No) Central venous line previous or current (Yes / No) Side of the central venous line if place (Left / Right)

Non-obligatory parameters (parameters B):

Smoking history (Yes / No) Hypertension (Yes / No) Heart failure (Yes / No) Ischemic heart disease (Yes / No) Cancer (previous or current) (Yes / No)

In order to evaluate uninterrupted use of the vascular access for dialysis (part 2 of the study), we will follow the patients and do a time to event analysis of the arteriovenous accesses for one year after creation or up until the first intervention for maintaining patency has been performed. If the patient dies during follow up the date of death should be recorded. The data for this part will be collected prospectively (Belfast City Hospital, UK, University hospital Královské Vinohrady Prague, CZ and other centres).

Predictive models will be used for validation of AVAS classification. The data will be registered via electronic database and analysed by Waldauf, P. and O'Neill, S.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 10034
        • Vascular surgery, University hospital Královské Vinohrady

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

- patients with kidney insufficiency who are indicated for creation of arterio venouss access for dialysis

Description

Inclusion Criteria:

  • patients indicated for creation of arterio venous access for dialysis

Exclusion Criteria:

  • patients who disagree to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterio Venous Access Stage (AVAS) evaluation
Time Frame: Baseline - recruiting (Year 1) - physical examination, data collection and evaluation of Arterio Venous Access Stage (AVAS)
What type of the Arterio Venous Access Stage (AVAS classification) the patient has based on his/her vascular anatomy of upper limbs
Baseline - recruiting (Year 1) - physical examination, data collection and evaluation of Arterio Venous Access Stage (AVAS)
Arterio Venous Access type predicted
Time Frame: Baseline - recruiting (Year 1) - physical examination, data collection and evaluation of Arterio Venous Access Stage (AVAS) and predicting a type of arterio venous access
What type of the Arterio Venous Access is predicted based on AVAS and other clinical factors
Baseline - recruiting (Year 1) - physical examination, data collection and evaluation of Arterio Venous Access Stage (AVAS) and predicting a type of arterio venous access
Final Arterio Venous Access
Time Frame: Follow up (up to 1-2 years) what type of arterio venous access was eventually created
What type of the arterio venous access was eventually created (in corelation with AVAS evaluation and the predicted arteriovenous access type)
Follow up (up to 1-2 years) what type of arterio venous access was eventually created
Functionality of the arterio venous access
Time Frame: Year 2-3 - follow up, collection the data about the functionality (uninterrupted use) of the arterio venous access and evaluation of the relation between AVAS and the functionality of the arterio venous access
Uninterrupted use of the created arterio venous access
Year 2-3 - follow up, collection the data about the functionality (uninterrupted use) of the arterio venous access and evaluation of the relation between AVAS and the functionality of the arterio venous access

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vascular surgery, University hospital Královské Vinohrady, Prague

Collaborators

Belfast Health and Social Care Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 532021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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