Preservation of donor liver before transplant Other
Conditions
Interventions
Study cohort (normothermic machine perfusion
NMP):
Prospectively identified, consecutive liver offers with a donor utilisation index (DUI) > 0.27, in which NMP is made available
NMP with oxygenated blood, using the OrganOx metra, prior to implan
SCS):
A priori defined real-world control cohort meeting study inclusion criteria, identified from the NHSBT registry, in which NMP was not used.
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: The enrolled entity in this study is a liver offer, rather than a transplant recipient. Inclusion criteria for liver offers: 1. Deceased donors aged 16 years or over 2. Offered through the national offering scheme 3. Donor Utilisation Index (DUI) greater than 0.27 Inclusion criteria for liver transplant recipients: 1. Recipients 18 years of age or above 2. Elective and super-urgent 3. Participant is willing and able to give informed consent for participation in the study
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 06/06/2023: Exclusion criteria for liver offers: 1. Donors falling outside national offering scheme 2. Donors from outside of the UK 3. Donor is HIV or hepatitis C positive 4. Donor Utilisation Index =0.27 5. Donor not ?donation after brain death (DBD) or donation after circulatory death (DCD) 6. Donors aged <16 years 7. Livers undergoing any other form of ex-situ machine preservation 8. Participating centre cannot offer NMP due to logistical reasons (e.g., lack of appropriate personnel or device availability) Liver transplant recipients: 1. Have not agreed to use of NMP according to local consent policy 2. Receipt of a split liver or reduced liver transplant 3. Receipt of a multi-organ transplant 4. Transplanted outside of the 7 participating centres Previous exclusion criteria: Exclusion criteria for liver offers: 1. Donors falling outside national offering scheme 2. Donors where information about participation was not sent with the organ offer 3. Donors from outside of the UK 4. Donor is HIV or hepatitis C positive 5. Livers undergoing any other form of ex-vivo machine preservation 6. Participating centre cannot offer NMP due to device, logistical or staffing reasons Liver transplant recipients: 1. Receipt of a liver that has not been recruited to the study 2. Have not agreed to use of NMP according to local consent policy 3. Receipt of a split liver transplant 4. Receipt of a multi-organ transplant 5. Transplanted outside of the 7 participating centres
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional utilisation defined as the defined as the number of livers transplanted where the patient is alive, without the need for a re-transplant, 12 months postoperatively. This is a binary outcome extracted from records held by the UK Transplant Registry (UKTR). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Graft survival defined as a functioning transplant in the absence of death and re-transplantation (death censored). These are measured at 7 days, 3 and 12 months and 5 years following re-transplantation. These are time to event outcomes and are also based on records held by the UK Transplant Registry (UKTR). 2. Graft loss including death or re-transplantation. These are measured at 7 days, 3 and 12 months and 5 years following transplantation. These are time to event outcomes and are also based on records held by the UK Transplant Registry (UKTR). 3. Patient survival at 7 days, 3 and 12 months and 5 years following transplantation. These are time to event outcomes and are also based on records held by the UK Transplant Registry (UKTR). 4. Primary non-function, defined as irreversible graft dysfunction requiring emergency liver replacement during the first 10 days after liver transplantation, in the absence of technical or immunological causes. This is a binary outcome extracted from records held by the UK Transplant Registry (UKTR). 5. NHS resource use based on published data and hospital episode statistics on the number of inpatient and outpatients’ episodes and treatments at 7 days, 3 and 12 months from Hospital Episode Statistics (HES) data. These will be valued using standard NHS unit costs. 6. Health-related quality of life for patients on the waiting list and post-transplant at 3 and 12 months, assessed by completion of the EQ-5D-5L questionnaire. 7. Post-operative resource use and quality of life (comparative and collected for both the study and historical cohort from data extracted from records held by the UK Transplant Registry) 7.1. Length of stay in high level (HDU/ITU) care post-transplant (days). 7.2. Length of initial hospital stay post-transplant (days). 7.3. Need for renal replacement therapy (haemodialysis, haemofiltration, haemodiafiltration) measured during transplant admission. The data indicate transient filtration, short or long-term | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactCharlie Brown
Outcome results
None listed