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Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
Sponsor: University Medical Center Groningen
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.
Official title: Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe (REFRAME-MP)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
10000
Start Date
2026-04-21
Completion Date
2030-12-31
Last Updated
2026-11-03
Healthy Volunteers
No
Interventions
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.
Locations (38)
Medical University of Innsbruck
Innsbruck, Austria
Medical University of Vienna
Vienna, Austria
Cliniques universitaires Saint-Luc
Brussels, Belgium
UZ Ghent
Ghent, Belgium
University Hospitals Leuven
Leuven, Belgium
Beaujon Hospital
Clichy, France
Hôpital de la Croix-Rousse
Lyon, France
Hautepierre Hospital
Strasbourg, France
Hôpital Paul-Brousse Ap-Hp
Villejuif, France
Aachen University Hospital
Aachen, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
University Hospital Bonn
Bonn, Germany
University Hospital Essen
Essen, Germany
Hannover Medical School
Hanover, Germany
University Hospital Heidelberg
Heidelberg, Germany
University Hospital Magdeburg
Magdeburg, Germany
University Hospital Muenster
Münster, Germany
Tübingen University Hospital
Tübingen, Germany
A.O.U Consorziale Policlinico di Bari
Bari, Italy
Ospedale Papa Giovanni XXIII
Bergamo, Italy
Policlinico S.Orsola-Malpighi
Bologna, Italy
ASST Niguarda Great Metropolitan Hospital
Milan, Italy
Istituto Nazionale dei Tumori
Milan, Italy
A.O.U. Pisana - Ospedale Cisanello
Pisa, Italy
Clinica ospedaliero-universitaria Policlinico Umberto I
Roma, Italy
A.O.U. Città della Salute e della Scienza
Torino, Italy
A.O.U. Integrata Verona
Verona, Italy
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Cruces University Hospital
Barakaldo, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Karolinska Institutet
Stockholm, Sweden
Bern University Hospital
Bern, Switzerland
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Royal Free London NHS Foundation Trust
London, United Kingdom