For clinicians

OrQA-UK

This page is for clinicians and surgeons who need key information and resources relating to the OrQA study. It includes essential trial documentation and materials to support understanding of the study and its governance.

Trial homepage For patients and public

End-user Device Deficiency Reporting form

This Device Deficiency Reporting form is to be used by the end users (surgeons) of the OrQA-L device to report Device Deficiencies to the NHSBT CTU team. Please complete and submit this form within 3 calendar days of awareness of the event.

To access the form, click here.

About the trial

OrQA-UK trial design, criteria and outcomes information can be found in the sections below.

Primary and secondary objectives

Primary endpoint/outcome

Eligibility Criteria

Inclusion Criteria

Donor family consent for research provided and no restrictions against commercial involvement, confirmed in TransplantPath
Donor liver with at least one back-bench image, confirmed in TransplantPath
Has assigned Donor ODT number, confirmed in TransplantPath
Donor type (DCD/DBD) provided, confirmed in TransplantPath
Liver image(s) passes OrQA image quality check, confirmed by the OrQA system
Liver image(s) passes OrQA liver/non-liver check, confirmed by the OrQA system
OrQA score completed by the OrQA system

Exclusion Criteria

Liver donor livers, confirmed in TransplantPath
Livers not offered through TransplantPath (Domino), confirmed in TransplantPath

Trial Design

The OrQA-UK trial is a pragmatic, decentralised, phase 3, parallel, two-stage group sequential randomised controlled trial. The two-stage group sequential design allows for one planned interim analysis for efficacy or futility after 60% recruitment.

The interim analysis will use O'Brien-Fleming stopping guidelines. The Dara Monitoring Committee (DMC) will review the results of the interim analysis and summarise their recommendations to the Trial Steering Committee (TSC).

Trial Setting

The OrQA-UK Trial will take place on the electronic TransplantPath platform used by NHS Blood and Transplant for transplant liver offering in the UK. No deviations to the standard national organ donation and transplantation processes will occur.

There are no participating sites in the trial. Transplant teams at all 8 of the Great Britain liver transplant centres will have access to the OrQA scores alongside the standard clinical information provided at the time of organ offering.

Patients are not directly recruited into this trial. The randomised entity in this trial is a donor liver.

Preclinical publications