Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT07315204

Conditions

Liver Transplant Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07315204

Start date

Mar 13, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

850 participants

Anticipated

Interventions and Outcome Measures

Arms

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 and Locations

Central contacts

Mary Bilancini, MS

216-444-8983bilancm@ccf.org

Erlind Allkushi, BS

216-444-0223allkuse2@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Andrea Schlegel, MD, MBA

216-339-0741schlega4@ccf.org

Mary Bilancini, MS

216-444-8983bilancm@ccf.org

Principal Investigator:

Andrea Schlegel, MD, MBA

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jun 4, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-06-04.