The OrQA-UK (Organ Quality Assessment) trial: testing a new artificial intelligence tool to help increase the use of donated livers in the UK
| ISRCTN | ISRCTN16126004 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16126004 |
| Integrated Research Application System (IRAS) | 354517 |
| Central Portfolio Management System (CPMS) | 64647 |
| National Institute for Health and Care Research (NIHR) | 208448 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust |
| Funder | National Institute for Health and Care Research |
- Submission date
- 19/05/2026
- Registration date
- 29/05/2026
- Last edited
- 29/05/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Organ transplants have transformed the prospects for patients with organ failure, but there are fewer organs available to transplant than people needing them. Those available are under-used because of concerns about quality.
Liver quality can be assessed by sending a biopsy to a laboratory, but this costs time and money. Photographs of organs are often used as part of decision-making through the TransplantPath NHS online platform, which is used for transplant administration, but image quality is varied and open to error. This means that transplant services rely on surgeons taking out the donor organs to judge their quality and health by how they look and feel. Transplant surgeons will often play it safe, for example by overestimating the amount of fat in a liver. This cautious approach means that some good quality organs may not be used.
Our team has developed an Artificial Intelligence-powered tool (OrQA, Organ Quality Assessment) that can standardise an organ photograph by accurately assessing the organ’s quality and providing an OrQA quality score. The aim of the OrQA-UK clinical trial is to show that the OrQA-Liver (OrQA-L) quality score can assist transplant surgeons in evaluating the quality of donated livers, and reduce the rate at which donated livers are not used by 25%. This could mean 60 extra liver transplants taking place a year.
Who can participate?
This trial does not recruit participants, it enrols donor livers as the trial entity
What does the study involve?
In this clinical trial, photographs of livers will be randomly allocated to either having an OrQA-L quality score displayed with them, or not. The scores will be displayed alongside the liver images for transplant surgeons to see. This will mean we can assess scientifically if the OrQA-L quality score is helpful to surgeons, while still ensuring patient safety.
What are the possible benefits and risks of participating?
N/A, participants are not directly recruited into this study
Where is the study run from?
The study is Sponsored by Newcastle Upon Tyne Hospitals NHSFT who have delegated trial management to the NHS Blood & Transplant Clinical Trials Unit based in Cambridge
When is the study starting and how long is it expected to run for?
Expected to start in August 2026 until January 2029
Who is funding the study?
NIHR Invention for Innovation Programme
Who is the main contact?
The OrQA-UK trial team at NHSBT Clinical Trials Unit, OrQATrial@nhsbt.nhs.uk
Contact information
Public, Scientific
NHSBT Clinical Trials Unit Cambridge
Long Road
Cambridge
CB2 0PT
United Kingdom
| Phone | +44 7553 525940 |
|---|---|
| charlotte.hickman@nhsbt.nhs.uk |
Principal investigator
Honorary Professor of Transplantation and Hepato-Pancreato-Biliary Surgery, Newcastle-Upon-Tyne Hospitals NHSFT
Newcastle-Upon-Tyne
NE1 4LP
United Kingdom
 ORCID ID |
0000-0002-1515-8690 |
|---|---|
| Phone | +44 7801414519 |
| colin.wilson6@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Diagnostic, Screening |
| Scientific title | OrQA-UK (Organ Quality Assessment): novel clinical trial of an AI enabled photograph assessment tool to improve organ utilisation in the United Kingdom |
| Study acronym | OrQA-UK trial |
| Study objectives | Primary Objective: To compare the non-use rate of livers between the control arm and intervention arm, which have the OrQA-L score displayed Secondary Objective: To assess the quality of the graft and transplant outcome Exploratory Objective: To compare the two arms using data obtained from livers which were perfused using ex-situ machine perfusion |
| Ethics approval(s) |
Approved 15/05/2026, Yorkshire & The Humber - Sheffield Research Ethics Committee (NHS Blood and Transplant Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 207 104 8010; sheffield.rec@hra.nhs.uk), ref: 26/YH/0086 |
| Health condition(s) or problem(s) studied | AI enabled photograph assessment tool to improve liver organ use in the United Kingdom |
| Intervention | Collection of follow up data from the NHSBT UK Transplant Registry, NHSBT statistician |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
Measured using Data taken from the UK Transplant Registry at Between transplantation and 3 months post-transplant: |
| Completion date | 01/01/2029 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 2040 |
| Key inclusion criteria | 1. Donor family consent for research provided and no restrictions against commercial involvement, confirmed in TransplantPath 2. Donor liver with at least one back-bench image, confirmed in TransplantPath 3. Has assigned Donor ODT number, confirmed in TransplantPath 4. Donor type (DCD/DBD) provided, confirmed in TransplantPath 5. Liver image(s) passes OrQA image quality check, confirmed by the OrQA system 6. Liver image(s) passes OrQA liver/non-liver check, confirmed by the OrQA system 7. OrQA-L score completed by the OrQA system |
| Key exclusion criteria | 1. Living donor livers, confirmed in TransplantPath 2. Livers not offered through TransplantPath (e.g. Domino), confirmed in TransplantPath |
| Date of first enrolment | 01/08/2026 |
| Date of final enrolment | 30/09/2028 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
-
-
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
19/05/2026: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
