Using FMN levels in perfusate and bile to check liver graft health during warm machine perfusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.