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

Condition(s) studied

Investigational drug(s) / intervention(s)

Endischemic 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.

Endischemic (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.

Continuous (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.

Endischemic 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.

Endischemic 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.

Normothermic regional perfusion (any device): Normothermic regional perfusion followed by static cold storage or any ex situ machine perfusion protocol.

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

Study 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

Primary outcome measure(s)

• Death-censored graft survival — Actuarial survival 1-5 year post-transplantation
  Defined as the time from liver transplantation until re-transplantation or death due to graft failure (analyzed using time-to-event methods).
• Overall patient survival — Actuarial survival 1-5 year post-transplantation
  Defined as time from liver transplantation until re-transplantation or all-cause death (analyzed using time-to-event methods).

Trial sites (18)

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