NCT03176433
Unknown
Phase 1
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
ConditionsLiver Transplantation
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Liver Transplantation
- Sponsor
- University of Oxford
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Patient and Graft Survival
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Patient and Graft Survival
Time Frame: 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 Outcomes
- Primary non-function(10 days)
- Adverse events, transplantation and organ discard rates.(30 days)
- Biliary investigation or intervention(6 months)
- Patient and Graft Survival(12 months)
- Peak serum AST (U/L)(7 days)
- Early allograft dysfunction (EAD)(7 days)
Study Sites (3)
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