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
This trial does not accept healthy volunteersQualifiers
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 population
All postmortal livers accepted (transplanted and not-transplanted after machine perfusion) upon organ offer between 01.01.2021 and 31.12.2025 for patients \>18 years at the time of liver transplantation.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Endischemic hypothermic oxygenated machine perfusion (any device)
DeviceEndischemic 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)
DeviceEndischemic (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)
DeviceContinuous (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)
DeviceEndischemic 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)
DeviceEndischemic 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)
DeviceNormothermic regional perfusion followed by static cold storage or any ex situ machine perfusion protocol.
Static cold storage
Other interventionPreservation with static cold storage only, not preceeded by NRP, nor followed by ex situ machine perfusion.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Death-censored graft survival
Defined as the time from liver transplantation until re-transplantation or death due to graft failure (analyzed using time-to-event methods).
Time frame
Actuarial survival 1-5 year post-transplantation2
Overall patient survival
Defined as time from liver transplantation until re-transplantation or all-cause death (analyzed using time-to-event methods).
Time frame
Actuarial survival 1-5 year post-transplantationSecondary outcomes
1
Overall graft survival
Defined as time from liver transplantation until re-transplantation or all-cause death (analyzed using time-to-event methods)
Time frame
Actuarial survival 1-5 year post-transplantation2
Incidence of major liver-related complications
Incidence of at least one biliary or vascular complication graded as Clavien-Dindo IIIb or higher, following the grading recommendations published: de Goeij FHC, Wehrle CJ, Abbassi F, et al. Mastering the narrative: Precision reporting of risk and outcomes in liver transplantation. J Hepatol. 2025;82(4):729-743. doi:10.1016/j.jhep.2024.11.013. Additionally, scoring accoring the Comprehensive Complication Index.
Time frame
within the transplant-related admission, and 1 year post-transplantation3
Incidence of graft loss due to complications
Graft loss as a result of complications assessed separately for biliary complications, vascular complications, and rejection.
Time frame
within 1 year post-transplantation, up to 5 years post-transplantation4
Total number of clinically significant biliary complications
Total number of any biliary complications requiring interventions (Clavien-Dindo grade IIIa or higher).
Time frame
within 1 year post-transplantation, up to 5 years post-transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Medical Center Groningen
Lead sponsor
A.O.U. Città della Salute e della Scienza
Collaborator
Source ClinicalTrials.gov