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

NCT07315204 | Recruiting

• 1 other identifier: 25-839
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Transplant Disorder

Keywords

normothermic machine perfusion; flavin mononucleotide; graft viability; liver transplant; OrganOx metra

Outcome Measures

Primary Outcomes (1)

• Graft functionality as measured by FMN correlation with graft viability at 1 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.

  1 year post transplant

Secondary Outcomes (10)

• Clinically significant non-anastomotic strictures

  within 1 year post-transplant

• Number/percentage of biliary complications

  within 1 year post-transplant

• Clinically significant NAS leading to graft loss

  within 1 year post-transplant

• Number of interventions required per NAS

  within 1 year post-transplant

• Number of complications according to Clavien-Dindo grading and comprehensive Complications Index (CCI)

  within 1 year post-transplant

Study Arms (1)

Recipients who receive deceased-donor liver transplant using machine perfusion with OrganOx metra

Normothermic perfusion using OrganOx metra. Can be from DBD or DCD donor.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recipients of deceased-donor liver transplant (DCD and DBD) will be recruited from outpatient clinics and inpatient services at the Cleveland Clinic Foundation Main Campus in the department of liver transplant. Patients will undergo their complete liver transplant work-up as directed by the multi-disciplinary selection committee and under the national direction of the United Network for Organ Sharing (UNOS). After completing their work-up, patients are discussed at the Liver Transplant Selection Committee, who must come to a consensus agreement regarding a candidate's eligibility prior to transplant. Each patient undergoing primary liver transplantation alone for end stage liver disease and/or liver tumor is eligible once approved by the committee, because this is an observational study comparing perfusion samples with standard-of-care clinical outcomes. Participating centers in this study will follow the standard procedures of their respective institutions.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Study Officials

• Andrea Schlegel, MD, MBA

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Bilancini, MS

CONTACT

216-444-8983; bilancm@ccf.org

Erlind Allkushi, BS

CONTACT

216-444-0223; allkuse2@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Abdominal Transplant Research

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)