Viability Assessment Using Flavin Mononucleotide (FMN) Measured in Perfusate and Bile During Normothermic Machine Perfusion: An International, Multi-center Validation Study

What this Trial Is About

Researchers are studying liver transplant patients to evaluate the use of Flavin Mononucleotide (FMN) levels measured in perfusate and bile during normothermic machine perfusion (NMP) as markers of graft viability. This multicenter observational study involves donors after circulatory death (DCD) or brain death (DBD) and aims to validate FMN as a predictor of graft function and complications up to one year after transplant. The study is led by the Cleveland Clinic and includes multiple sites in the US and UK. During the study, discarded perfusate samples will be collected from donor organs while on the OrganOx metra device for normothermic machine perfusion prior to transplantation. FMN levels will be measured as part of standard care for all machine perfusion liver transplant cases. The transplant procedure will then continue as usual following sample collection. Samples from outside sites will be collected following strict shipping and preservation guidelines but will be discarded after analysis. Participants will undergo liver transplantation with back-to-base NMP using the OrganOx metra device. Researchers will monitor graft functionality by measuring FMN levels in perfusate and bile and correlate these with post-transplant outcomes such as graft loss, biliary complications, vascular issues, rejection episodes, and other related complications for up to one year. Data on interventions needed and severity of complications will also be collected. The study includes both retrospective and prospective patient enrollment with follow-up assessments to validate FMN as a clinical viability marker.

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