Discarded perfusate samples will be collected from donors after circulatory death (DCD) or donors after brain death (DBD) organs during the machine perfusion period prior to transplantation by the study team. FMN will be measured as is standard of care for all machine perfusion liver transplant cases at Cleveland Clinic.
Participating centers will be provided with sample collection and shipping instructions to ensure sample preservation in accordance with IATA guidelines. Samples from outside sites will not be stored for future research and will be discarded once analysis is completed.
After the collection of the samples from machine perfusion, the transplant procedure will continue according to standard process.
Age >18 years
Any graft type (DBD or DCD)
Any underlying recipient disease (i.e., end stage, liver tumour)
Any other donor risk factors and static cold storage time prior to NMP accepted by the participating center for transplantation in context of OrganOx metra use
Patients receiving a liver graft that is not perfused with OrganOx metra
Pediatric recipients (<18years)
Patients listed for super urgent liver transplantation due to acute liver failure
Patients receiving combined organ transplant (heart+liver, lung+liver, liver+kidney, liver+intestine)
Recipients of deceased-donor liver transplant (DCD and DBD) will be recruited from outpatient clinics and inpatient services at the Cleveland Clinic Foundation Main Campus in the department of liver transplant. Patients will undergo their complete liver transplant work-up as directed by the multi-disciplinary selection committee and under the national direction of the United Network for Organ Sharing (UNOS). After completing their work-up, patients are discussed at the Liver Transplant Selection Committee, who must come to a consensus agreement regarding a candidate's eligibility prior to transplant. Each patient undergoing primary liver transplantation alone for end stage liver disease and/or liver tumor is eligible once approved by the committee, because this is an observational study comparing perfusion samples with standard-of-care clinical outcomes. Participating centers in this study will follow the standard procedures of their respective institutions.
Cohort
Other
Not listed
Graft functionality as measured by FMN correlation with graft viability at 1 year post transplant
Graft functionality measured by perfusate FMN, bile FMN, and perfusate + bile FMN. Graft viability measured by primary non-function (PNF). Non-anastomotic stricture (NAS), other graft related loss - death censored.
Clinically significant non-anastomotic strictures
Number of non-anastomotic strictures requiring intervention
Number/percentage of biliary complications
Biliary complications include anastomotic stricture (AS), NAS, bile leaks, as seen on imaging, ERCP/MRCP.
Clinically significant NAS leading to graft loss
Number of non-anastomotic strictures that result in graft failure
Number of interventions required per NAS
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