NCT07315204 Viability Assessment Using FMN Measured in Perfusate and Bile During Normothermic Machine Perfusion
| NCT ID | NCT07315204 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Liver Transplant Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 850 participants |
| Start Date | 2026-03-13 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 850 participants in total. It began in 2026-03-13 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Andrea Schlegel, MD, MBA
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT07315204 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Transplant Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07315204 currently recruiting?
Yes, NCT07315204 is actively recruiting participants. Contact the research team at bilancm@ccf.org for enrollment information.
Where is the NCT07315204 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07315204 clinical trial?
NCT07315204 is sponsored by The Cleveland Clinic. The principal investigator is Andrea Schlegel, MD, MBA at The Cleveland Clinic. The trial plans to enroll 850 participants.