Using FMN levels in perfusate and bile to check liver graft health during warm machine perfusion
Viability Assessment Using Flavin Mononucleotide (FMN) Measured in Perfusate and Bile During Normothermic Machine Perfusion: an International, Multi-center Validation Study
This project will test whether measuring flavin mononucleotide (FMN) in perfusate and bile during normothermic machine perfusion can help identify which adult deceased-donor livers are safe to transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 850 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07315204 on ClinicalTrials.gov |
What this trial studies
The team will collect discarded perfusate (and bile when available) from adult deceased-donor livers undergoing back-to-base normothermic machine perfusion with the OrganOx metra at Cleveland Clinic and measure FMN concentrations as part of routine care. Samples will be handled and shipped according to IATA guidelines and analyzed without being stored long-term. This observational approach links real-time FMN measurements to existing perfusion parameters and subsequent transplant outcomes. The goal is to determine whether FMN, a marker of mitochondrial injury shown useful in HOPE-perfused grafts, provides actionable viability information during NMP.
Who should consider this trial
Good fit: Adults (age >18) receiving primary deceased-donor liver transplants at Cleveland Clinic where back-to-base OrganOx metra normothermic machine perfusion is used are the intended candidates.
Not a fit: Pediatric recipients, living-donor or combined-organ transplant recipients, patients receiving grafts not perfused with OrganOx metra, and super-urgent acute liver failure cases are excluded and likely will not benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide a quick biological marker to improve graft selection, reduce graft loss and lower posttransplant complications.
How similar studies have performed: Prior work has shown FMN measured during HOPE correlates with posttransplant outcomes and reduced graft loss and non-anastomotic strictures in European cohorts, but applying FMN monitoring during NMP is less established.
Eligibility criteria
Show full inclusion / exclusion 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 (\<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) * Patients receiving living donor liver transplant or a split (or reduced) liver transplantation or a domino graft. * Re-transplantations
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Andrea Schlegel, MD, MBA — The Cleveland Clinic
- Study coordinator: Mary Bilancini, MS
- Email: bilancm@ccf.org
- Phone: 216-444-8983
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.