RecruitingNCT07585890

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

Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe (REFRAME-MP)


Sponsor

University Medical Center Groningen

Enrollment

10,000 participants

Start Date

Apr 21, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Continuous (device-to-donor) normothermic machine perfusion (any device), Endischemic (back-to-base) normothermic machine perfusion (any device), and others for people with acute liver failure, end-stage liver disease (esld), and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEndischemic hypothermic oxygenated machine perfusion (any device)

Endischemic single- or dual hypothermic oxygenated machine perfusion. Normothermic regional perfusion prior to single- or dual hypothermic oxygenated machine perfusion is eligible for inclusion.

DEVICEEndischemic (back-to-base) normothermic machine perfusion (any device)

Endischemic (back-to-base) normothermic machine perfusion. Normothermic regional perfusion prior to endischemic (back-to-base) normothermic machine perfusion is eligible for inclusion.

DEVICEContinuous (device-to-donor) normothermic machine perfusion (any device)

Continuous (device-to-donor) normothermic machine perfusion. Normothermic regional perfusion prior to continuous (device-to-donor) normothermic machine perfusion is eligible for inclusion.

DEVICEEndischemic HOPE-COR-NMP (any device)

Endischemic single or dual hypothermic oxygenated machine perfusion followed by controlled oxygenated rewarming and normothermic machine perfusion. Normothermic regional perfusion prior to HOPE-COR-NMP is eligible for inclusion.

DEVICEEndischemic HOPE-NMP (any device)

Endischemic single or dual hypothermic oxygenated machine perfusion followed by normothermic machine perfusion. Normothermic regional perfusion prior to HOPE-NMP is eligible for inclusion.

DEVICENormothermic regional perfusion (any device)

Normothermic regional perfusion followed by static cold storage or any ex situ machine perfusion protocol.

OTHERStatic cold storage

Preservation with static cold storage only, not preceeded by NRP, nor followed by ex situ machine perfusion.


Locations(2)

A.O.U. Città della Salute e della Scienza

Torino, Italy

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

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NCT07585890


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