For investigators

NHS Blood and Transplant (NHSBT) has been highly successful in increasing organ donation rates in order to meet waiting list demands, but the quality and utilisation of donated organs is now a key concern.

We hypothesise that through the reduction of intrahepatic triglyceride (IHTG) content, steatotic livers can be optimised for safe transplantation.

Participant inclusion criteria 

Donor livers:

• donors aged 18 years or over
• offered through the national offering scheme and accepted by participating liver transplant centre
• moderate-severe steatosis: macroscopic characteristics based on colour, texture, rounded edges, size and weight at point of inspection at the transplant hospital to confirm suitability for randomisation. Where available, the results of clinical biopsies demonstrating moderate-severe steatosis (typically >30%) will also be considered to assess suitability for randomisation

Liver transplant recipients:

• recipients 18 years of age or above
• elective waiting list at a participating centre
• willing to consent for inclusion into the study and collection and use of their data
  
  

Participant exclusion criteria 

Donor livers:

• donors from outside of the UK
• donor is HIV, hepatitis B or C positive
• cold ischaemia time (CIT) expected to exceed > 10 hours
• macroscopic evidence of fibrosis
• livers undergoing any other form of ex-situ machine preservation
• participating centre cannot offer NMP due to device, logistical or staffing reasons

Liver transplant recipients:

• receipt of a liver that has not undergone randomisation
• receipt of super urgent transplant for acute liver failure
• receipt of a split liver transplant
• receipt of a multi-organ transplant
• transplanted outside of the participating centres
• contra-indication to MRI e.g. pacemaker

The primary endpoint is the proportion of livers that achieve all of the following functional criteria at 6 hours of perfusion, as defined by:

• Clearance of lactate to a level < 2.5 mmol/L
• Perfusate pH >20
• Evidence of glucose metabolism (spontaneous fall in perfusate glucose)
• Minimum bile pH >5 (if bile produced)
• Bile glucose concentration < 3 mmol/L or > 10 mmol less than perfusate glucose
• Hepatic criterial flow > 100 ml/min; portal venous flow > 500 ml/min
• Perfusate alanine aminotransferase (ALT) < 6000 U/L at 6 hours

Secondary endpoints include proportion of livers transplanted, clinical and safety outcomes.