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Observational Study on Liver Transplant Viability Using FMN

This observational study is looking at how well a marker called FMN (Flavin Mononucleotide) can predict the success of liver transplants. FMN is a sign of mitochondrial injury, which means damage to the powerhouses of cells. Researchers will collect discarded fluid samples from donor livers during a process called normothermic machine perfusion (NMP), which keeps the liver alive outside the body before transplant. They will measure FMN levels in these samples. The goal is to see if FMN levels measured during NMP can help doctors understand how well a transplanted liver will work one year after surgery. You may be eligible if you are over 18 and receiving a deceased donor liver transplant where NMP is used. The study status is currently unclear.

Study design
This is an observational study planning to enroll 850 participants. It is not a randomized or blinded study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will assess graft functionality one year after your transplant to see how well the liver is working.

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NCT07315204

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

Recruiting
Not specifiedAges 18+Observational
The Cleveland Clinic
~850 participants
Updated 2026-06-04 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Graft functionality as measured by FMN correlation with graft viability at 1 year post transplant
Measured over 1 year post transplant

Conditions

Liver Transplant Disorder

Explore related trials

Liver Transplantation

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Andrea Schlegel, MD, MBA · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Mary Bilancini, MS
[email protected]
216-444-8983
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Graft functionality as measured by FMN correlation with graft viability at 1 year post transplant1 year post transplant

    Graft functionality measured by perfusate FMN, bile FMN, and perfusate + bile FMN. Graft viability measured by primary non-function (PNF). Non-anastomotic stricture (NAS), other graft related loss - death censored.