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

About the trial

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

Primary and secondary objectives

Outcome measures/endpoints

Organs allocated for deceased donor liver transplantation are evaluated for individual recipients by liver transplant clinicians based on multiple metrics:

Donor: recipient blood group compatibility (Critical)
Donor co-morbidity (including pre-existing infections, cancer, organ function)
Recipient status (elective, urgent, superurgent)
Donor: recipient size compatibility
Availability of organ perfusion technology
Donor status (Donor after circulatory death including warm ischaemic time, donor after brain stem death)
Donor organ quality/presence of macrosteatosis (ORQA)
Expected cold ischaemic time (time liver is out of the body)
Expected surgical hepatectomy time
Donor time on Intensive Care

Ultimately, if the organ is accepted and transplanted NHSBT mandate a return form from the transplant centre at 3 months (with a time window of 75 days to 4 months). The following metrics reflect the "quality" of the graft and transplant outcome and are available as part of these returns to UK Transplant Registry (UKTR) held by NHSBT:

Patient survival from the 3 month form.
Primary non-function (PNF). requiring retransplantation. Both PNF and the need for retransplantation are recorded in the registry.
Post transplant bleeding, transfusion, requirement for reoperation. This is collected as part of a field 'Haemorrhage requiring reoperation'.
Graft survival from the 3-month form.
Hepatic artery thrombosis up to 3 months.
Acute kidney injury, captured by renal status on the 3-month form (no or minor renal impairment, required transient renal filtration, short-term dialysis or long-term dialysis).
Early anastomotic biliary complications - biliary tract leaks and biliary tract stricture requiring intervention are on the 3-month form.
Post-operative wound sepsis and fungal infections from the 3-month form.
Number of treated rejection episodes since transplant from the 3-month form.

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.