We are studying the effect of using normothermic liver perfusion to preserve the donor liver on the outcomes of liver transplantation. The disease common to all the recipients is end-stage liver failure. Surgery
Conditions
Interventions
The intervention is 'Normothermic liver perfusion'.
The current standard method of storing and preserving a liver for transplant after it has been removed from the donor is by flushing it with a cold
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Donor Inclusion Criteria: 1. Donors over the age of 16 years. 2. Liver allografts from donation after brain death (DBD), standard and extended criteria donors (SCD, ECD) and donation after circulatory death (DCD) donors. Recipient Inclusion Criteria: 1. Adult patients (18 years or more) 2. Active on the waiting list for liver transplantation 3. Able to give informed consent.
Exclusion criteria
Exclusion criteria: Donor Exclusion Criteria: 1. Living donors 2. Liver intended for split transplant 3. Donor age <16 years 4. Liver in which investigator is unwilling to randomise to either arm Recipient Exclusion Criteria: 1. Age less than 18 years 2. Acute/fulminant liver failure 3. Transplantation of more than one organ (e.g. liver and kidney) 4. Refusal of informed consent 5. Unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in peak serum aspartate transaminase level (AST) within 7 days post-transplant between the two treatment arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare graft and patient survival between NMP and SCS livers. 1. Primary non-function: irreversible graft dysfunction requiring emergency liver replacement during the first 10 days after liver transplantation, in the absence of technical or immunological causes. 2. Graft survival at 30 days and 6, 12 and 24 months following transplantation. 3. Patient survival at 30 days and 6, 12 and 24 months following transplantation. To compare biochemical liver function between NMP and SCS livers. 1. Daily serum bilirubin, GGT, AST and INR at days 1-7 following transplantation. 2. Daily serum lactate at days 1-7 whilst in high level (ITU/HDU) care 3. Serum bilirubin, GGT, AST and INR at day 30 and months 6, 12 and 24 following transplantation. 4. Early allograft dysfunction (EAD) [41]; defined by any one of: 4.1. Bilirubin >170 ìmol/l (10mg/dL) on day 7 post-transplant 4.2. INR >1.6 on day 7 post-transplant. 4.3. Peak aspartate transaminase (AST) >2000 IU/L within the first 7 days post-transplant To compare the physiological response to reperfusion between NMP and SCS livers 1. Post-reperfusion syndrome, defined as a decrease in mean arterial pressure (MAP) of more than 30% from the baseline value for more than one minute during the first five minutes after reperfusion. This will be assessed in the context of vasopressor use 2. Length of stay in high level (HDU/ITU) care 3. Length of hospital stay 4. Need for renal replacement therapy (haemodialysis, haemofiltration, haemodiafiltration) To compare evidence of reperfusion injury between NMP and SCS livers. 1. Histological evidence of reperfusion injury in post-reperfusion biopsies (taken immediately prior to abdominal closure). These will be compared to baseline pre-reperfusion biopsies (on removal of the liver from SCS/NMP) and graded using standard histological criteria To compare evidence of ischaemic cholangiopathy between NMP and SCS livers. 1. Evidence of biliary stricturing on magnetic resonance cholangio | — |
Countries
Belgium, Germany, Spain, United Kingdom
Outcome results
None listed