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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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 criteria

Qualifiers

All postmortal livers accepted (transplanted and not-transplanted after machine perfusion) upon organ offer for patients >18 years at the time of liver transplantation.

All donor types (DBD, DCD)

Preservation either with static cold storage alone or combined with machine perfusion (MP).

Donor livers underwent MP as part of routine clinical practice and the choice of perfusion protocol was made according to institutional standard practice.

Disqualifiers

Livers that were allocated to a MP protocol as part of a prospective randomized or interventional clinical trial comparing different preservation techniques or any other invention.

Living donor liver transplantation

Trial design

Treatments tested in this trial

  • Endischemic hypothermic oxygenated machine perfusion (any device)
  • Endischemic (back-to-base) normothermic machine perfusion (any device)
  • Continuous (device-to-donor) normothermic machine perfusion (any device)
  • Endischemic HOPE-COR-NMP (any device)
  • Endischemic HOPE-NMP (any device)
  • Normothermic regional perfusion (any device)
  • Static cold storage

Treatment groups

No treatment groups listed

Sponsors and collaborators

University Medical Center Groningen

Lead sponsor

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

Collaborator