About the trial

Utilisation of normothermic machine preservation in extended criteria livers: a national threshold-crossing study.

The dominant challenge in clinical organ transplantation is the shortage of deceased donor organs.

Liver transplantation is a highly effective treatment, however, livers from many donors are less suitable, due to older age, medical conditions or circumstances of death.

To use these higher-risk livers safely, we need to find better ways to preserve, repair and test livers so that more of the available donor organs can be transplanted without compromising the survival rate.

Normothermic machine perfusion (NMP) is a novel method of organ preservation which replaces the conventional icebox, using a machine which restores the flow of blood at body temperature allowing the liver to function during storage. This results in less injury and allows the surgeon to assess the organ’s viability.

This study will recruit 799 eligible livers at the point of offering and assess the impact of availability of NMP on organ utilisation on the entire transplant pathway. 

Eligibility is assessed by a clinical risk score which predicts graft utilisation. 

We will compare the proportion resulting in successful transplants with a group of offers where NMP was not used to see if a pre-defined threshold for increased use is met.The primary outcome is functional utilisation: transplantation of the liver with 12-month graft survival.

Data analysis

Recruitment for PLUS has finished and data analysis is underway. We aim to have the initial results published by the end of 2025.

The majority of data used for this research is held by NHS Blood and Transplant (NHSBT) in the UK Transplant Registry. Applications can be made to NHSBT for anonymised data – details are available on this webpage: Access data - ODT Clinical.

The data generated purely for the study will be available after publication as anonymised study datasets. Data requests should be submitted to the corresponding author, PLUS Study Chief Investigator, Professor Peter Friend (peter.friend@nds.ox.ac.uk) or the PLUS study team at the NHSBT Clinical Trials Unit (CTU@nhsbt.nhs.uk).

All data sharing requests for PLUS study data will require approval from the sponsor and the Trial Steering Committee. A data sharing agreement will also be required.

Download the trial protocol here: PLUS trial protocol (PDF 993 KB).

For more information about the study, please contact our team at PLUS@nhsbt.nhs.uk.