Vascular Access outcome measure for function: a vaLidation study In haemodialysis (VALID)
AKTN response plan for novel coronavirus (COVID-19) – VALID
In response to the COVID-19 pandemic and resultant burden on clinicians and health system, the AKTN has implemented adjustments to the following in the VALID trial in Australia and internationally:
- Activation of new sites will occur as sites are approved and have the ability to commence trial activities.
- Recruitment of new participants will occur as new sites are activated.
- Sites with enrolled participants will continue to be supported by the AKTN’s central support staff to continue data collection to the extent their individual circumstance and local restrictions allow. The Sponsors will continue to monitor the situation and will take appropriate action at site, region and trial level as appropriate. We appreciate your commitment and valuable contribution to the VALID trial.
- For sites not yet activated, AKTN will continue to support this process to have the sites ready to recruit when we re-start patient recruitment.
The AKTN will continue to monitor the situation and will recommence recruitment at an appropriate time. We appreciate your commitment and valuable contribution to the VALID trial.
Please contact the VALID team if you would like to discuss further on firstname.lastname@example.org.
Principal Investigators: Andrea Viecelli
Clinical Project Manager: Alyssa Welch (AKTN)
Clinical Research Associate: Andrea Valks (AKTN)
Trial Number: AKTN 19.01
Population: Patients 18 years old or over who are new to or established on chronic haemodialysis
Follow-up: 6 months
Primary outcome: Reporting of vascular access function during a 6 months period, defined by the need for any intervention(s) required to enable and maintain the use of a vascular access for HD
Status: Recruitment open
Target Recruitment: 612 participants across 10 centres across Australia, Europe, Canada, USA, China and Malaysia
VALID is a prospective, multi-centre, multinational validation study to assess the accuracy and feasibility of measuring vascular access function, defined as the need for interventions to enable and maintain the use of a vascular access for HD, by clinical staff as part of their routine clinical practice.
The study aims to assess the accuracy of collecting vascular access interventions required to enable and maintain the use of a vascular access for HD collected by clinical staff as part of routine clinical practice. It also aims to assess the feasibility of collecting vascular access interventions required to enable and maintain the use of a vascular access for HD as part of routine clinical practice.
The study has already received funding from the Jacquot Research Establishment Grant and a Princess Alexandra Research Foundation 2019 Research Award.