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NCT07315204
Viability Assessment Using FMN Measured in Perfusate and Bile During Normothermic Machine Perfusion
Conditions: Liver Transplant Disorder
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 850
Sponsor: The Cleveland Clinic
Location: Cleveland Clinic Foundation Cleveland Ohio
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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 undergoing primary deceased donor liver transplantation where back-to-base NMP is used (OrganOx metra) from July 15, 2025 to December 31, 2027. (CCF only)
* Patients who have undergone deceased donor liver transplantation where back-to-base NMP was used (OrganOx metra) from October 22, 2022 to July 14, 2025. (CCF only)
Exclusion Criteria:
* Patients receiving a liver graft that is not perfused with OrganOx metra
* Pediatric recipients (\
Source: ClinicalTrials.gov (NCT07315204). StuddyBuddy aggregates publicly available trial information.
