Liver Transplantation
Conditions
Brief summary
The aim of this study is to assess the safety and feasibility of a short period of cold storage prior to normothermic machine perfusion in adult liver transplantation.
Interventions
DEVICENormothermic Machine Liver Perfusion
Liver Preservation Method
Sponsors
University of Oxford
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Donor Inclusion Criteria: * Donors over the age of 16 years. * Liver allografts from donation after brain death (DBD), standard and extended criteria donors. (SCD, ECD) and donation after circulatory death (DCD) donors. * Liver must be perfused on OrganOx metra perfusion device within 8 hours of in situ cold perfusion. * The perfusion should last a minimum of 4 hours and maximum of 24 hours. Donor
Exclusion criteria
* Living donors. * Liver being transplanted as part of a multi-organ transplant (eg liver and kidney). * Liver intended for split transplant. * Donor age \<16 years * Liver which investigator is unwilling to recruit to study. * Any liver in which logistics prevent perfusion on the OrganOx metra perfusion device within 8 hours of in situ cold perfusion. Recipient Inclusion Criteria: * Adult patients (18 years or more). * Active on the waiting list for liver transplantation. * Able to give informed consent. Recipient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Graft Survival | 30 days | Patient survival after liver transplantation and liver graft survival will be assessed at 30-days post-op as a composite outcome measure. This will be recorded as yes/no outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early allograft dysfunction (EAD) | 7 days | This is a composite score which is used to predict longer-term outcome. It comprises: bilirubin \>or=10mg/dL on day 7 post-transplant, international normalized ratio \>or=1.6 on day 7 post-transplant, and alanine or aspartate aminotransferases \>2000 IU/L within the first 7 days post-transplant. This will be compared with matched controls of livers undergoing continuous NMP and SCS |
| Primary non-function | 10 days | This is irreversible graft dysfunction requiring emergency liver replacement during the first 10 days after liver transplantation, in the absence of technical or immunological causes. This will be compared with matched controls of livers undergoing continuous NMP and SCS |
| Peak serum AST (U/L) | 7 days | The highest AST level recorded in the first 7 days post-transplant will be identified. This is a surrogate marker for longer-term outcome. It will be compared with matched controls of livers undergoing continuous NMP and SCS |
| Biliary investigation or intervention | 6 months | In order to capture the incidence of ischaemic cholangiopathy, any biliary investigation (such as magnetic resonance imaging) or intervention (such as endoscopic retrograde cholangiopancreatography) will be recorded and compared with matched controls of livers undergoing continuous NMP and SCS |
| Patient and Graft Survival | 6 months | Patient survival after liver transplantation and liver graft survival will be assessed at 6 months post-op as a composite outcome measure. This will be recorded as yes/no outcome and compared controls undergoing continuous NMP and SCS |
| Adverse events, transplantation and organ discard rates. | 30 days | This composite outcome aims to establish safety and feasibility as well as organ utilisation. It will be compared with matched controls of livers undergoing continuous NMP and SCS |
Countries
United Kingdom
Contacts
Primary ContactCarlo DL Ceresa
Outcome results
None listed