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

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.

Conditions

• End-stage Liver Disease (ESLD)
• Acute Liver Failure
• Liver Cirrhosis
• Liver Transplantation

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

Normothermic regional perfusion (any device)

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

OTHER

Static cold storage

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

Sponsors & Collaborators

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

  collaborator OTHER

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Vincent E de Meijer, MD, PhD · University Medical Center Groningen

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-21

Primary Completion

2026-12-31

Completion

2030-12-31

Countries

• Italy
• Netherlands

Study Locations