For investigators
Information for investigators around trial design, criteria and outcomes.
![PLUS logo](https://nhsbtdbe.blob.core.windows.net/umbraco-assets-corp/25692/plus-logo-cropped.png)
Study hypothesis
Does the availability of normothermic machine perfusion in extended criteria livers improve utilisation without compromising outcome?
Eligibility criteria
Participant inclusion criteria
Liver offers:
- Deceased organ donors aged 16 years or over
- Offered through the national offering scheme
- Donor Utilisation Index (DUI) greater than 0.27
Livers undergoing normothermic regional perfusion (NRP) will be included in the study and use of NRP corrected for in analysis.
Liver transplant recipients:
- Recipients 18 years of age or above
- Elective and super-urgent
- Participant is willing and able to give informed consent for participation in the study
Participant exclusion criteria
Liver offers:
- Donors falling outside national offering scheme
- Donors where information about study participation was not sent with the organ offer
- Donors from outside of the UK
- Donor is HIV or hepatitis C positive
- Livers undergoing any other form of ex-vivo machine preservation
- Participating centre cannot offer NMP due to device, logistical or staffing reasons
Liver transplant recipients:
- Receipt of a liver that has not been recruited to the study
- Have not agreed to use of NMP according to local consent policy
- Receipt of a split liver transplant
- Receipt of a multi-organ transplant
- Transplanted outside of the 7 participating centres
Study Design
The PLUS study has a threshold-crossing design with a prospectively-defined efficacy threshold.
A real-world control cohort identified from the NHS Blood and Transplant registry, meeting study inclusion criteria in which normothermic machine perfusion (NMP) was not used.
A study cohort of prospectively identified, consecutive liver offers with a donor utilisation index >0.27* in which NMP is made available.
*A DUI of >0.27 represents the 60% least well utilised livers
Study outcomes
Primary outcome measure
Functional utilisation – transplantation of the liver with 12-month patient and graft survival
Secondary outcome measures
- Intervention costs, NHS resource use and quality of life
- Biochemical liver function
- Graft and patient survival
- Postoperative hospital resource
- Perfusion parameters, biomarkers in perfusion fluids and graft histology
- Safety outcomes
For more information about the study please contact our team at PLUS@nhsbt.nhs.uk.