Post Static Cold Storage Normothermic Machine Liver Perfusion

University of Oxford

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Liver Transplantation

Treatments: Device: Normothermic Machine Liver Perfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03176433

16/LO/2196

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)