VAVASC study: Clinical trial protocol

Abstract

Background: VAVASC study (Validation of Arterio Venous Access Stage Classification) is a multicentre, international, prospective study. The study aims to validate the AVAS classification, which is a classification system describing vascular status of patients indicated for creation of arteriovenous access on the upper limb.

Methods: Observational, prospective, multicentre, international study starting in March 2021. Participant recruitment has commenced. Basic demographic data, risk factors and vascular mapping parameters are collected via an online platform. The outcome measures are class of AVAS, predicted arteriovenous access, final arteriovenous access that has been created and a functionality of the arteriovenous access. Predictive models will be used for statistical analysis.

Current status: A total of 140 patients from 4 centres in Great Britain, Czech Republic, Brazil and Slovakia are already included and undergoing evaluation.

Conclusions: The study is registered in the Clinical trials registry (NCT04796558), https://register.clinicaltrials.gov/. Study is still open for collaboration with other centres that can register via www.vavasc.com.

Keywords: Arterio Venous Access Stage (AVAS); Validation of Arterio Venous Access Stage Classification (VAVASC); arteriovenous access; arteriovenous fistula; dialysis.