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

Conditions

• Liver Transplant Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Mar 13, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

850 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

Graft functionality as measured by FMN correlation with graft viability at 1 year post transplant [ Time Frame: 1 year post transplant ]

Central Contacts

• Mary Bilancini, MS
  216-444-8983
  [email protected]
• Erlind Allkushi, BS
  216-444-0223
  [email protected]

Locations (1)

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