Actively Recruiting

Age: 18Years +
All Genders
NCT07315204

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

Led by The Cleveland Clinic · Updated on 2026-01-07

850

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Any donor graft type (donation after brain death or circulatory death)
  • Any underlying recipient disease including end stage liver disease or liver tumor
  • Acceptable donor risk factors and static cold storage time prior to normothermic machine perfusion as approved by the transplant center
  • Patients undergoing primary deceased donor liver transplantation with back-to-base normothermic machine perfusion using OrganOx metra from July 15, 2025 to December 31, 2027 (Cleveland Clinic only)
  • Patients who underwent deceased donor liver transplantation with back-to-base normothermic machine perfusion using OrganOx metra from October 22, 2022 to July 14, 2025 (Cleveland Clinic only)
Not Eligible

You will not qualify if you...

  • Liver grafts not perfused with OrganOx metra
  • Pediatric recipients under 18 years old
  • Patients listed for super urgent liver transplantation due to acute liver failure
  • Patients receiving combined organ transplants (heart+liver, lung+liver, liver+kidney, liver+intestine)
  • Patients receiving living donor liver transplant, split or reduced liver transplantation, or domino grafts
  • Patients undergoing re-transplantation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

M

Mary Bilancini, MS

CONTACT

E

Erlind Allkushi, BS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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