Viability Assessment Using FMN Measured in Perfusate and Bile During Normothermic Machine Perfusion

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Cleveland Clinic

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

850 Participants
are grouped into 1 trial group

Sponsors and collaborators