Post Static Cold Storage Normothermic Machine Liver Perfusion

A Multicentre, Single-arm, Prospective Clinical Trial to Investigate the Safety and Feasibility of Cold Storage Prior to Normothermic Machine Perfusion in Adult Human Liver Transplantation

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.

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 Exclusion Criteria:

• Age less than 18 years.
• Acute/fulminant liver failure.
• Transplantation of more than one organ (e.g. liver and kidney).
• Refusal of informed consent.
• Unable to give informed consent.