Clinical Trial

Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe

Study acronym: REFRAME-MP
Recruiting
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Summary
Machine perfusion (MP) has become routine clinical practice in liver transplantation. However, as the field has matured, direct randomized comparisons between distinct MP modalities have become increasingly impractical, given that donor and graft characteristics often predetermine the optimal preservation strategy. Consequently, many studies continue to reference historical benchmark cohorts from the pre-perfusion era, or use risk scores developed before routine utilization of MP. These cohorts, while once valuable, fail to account for the paradigm shift that MP has introduced. Likewise, commonly used donor- and recipient-based risk scores were developed prior to the adoption of MP. While these scores aim to assess survival or morbidity after transplantation, none of them guide decisions about MP use or the most suitable perfusion protocol. As MP technologies continue to evolve there is a critical need for an updated reference framework that accurately reflects current clinical practice and captures the best achievable outcomes across all MP modalities.
Protocol Amendment History 1 change
notable Trial sites expanded: 2 -> 9 locations 2026-08-04
Trial Details
NCT Number NCT07585890
Lead Sponsor University Medical Center Groningen
Collaborators: A.O.U. Città della Salute e della Scienza
Conditions End-stage Liver Disease (ESLD), Acute Liver Failure, Liver Cirrhosis, Liver Transplantation
Enrollment 10,000 participants
Start Date 2026-04-21
Primary Completion 2026-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-03