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

NCT07585890 | Recruiting

• 2 other identifiers: UMCG_REFRAME-MPMETc 2026/180
• Study Type: observational
• Target: 10,000
• Locations: 2 countries
• Sites: 2

Brief 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); Liver Cirrhosis; Liver Transplantation; Acute Liver Failure

Keywords

machine perfusion; liver transplantation; hypothermic machine perfusion; normothermic machine perfusion; normothermic regional perfusion; organ preservation; machine preservation

Outcome Measures

Primary Outcomes (2)

• 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).

  Actuarial survival 1-5 year post-transplantation

• Overall patient survival

  Defined as time from liver transplantation until re-transplantation or all-cause death (analyzed using time-to-event methods).

  Actuarial survival 1-5 year post-transplantation

Secondary Outcomes (13)

• Overall graft survival

  Actuarial survival 1-5 year post-transplantation

• Incidence of major liver-related complications

  within the transplant-related admission, and 1 year post-transplantation

• Incidence of graft loss due to complications

  within 1 year post-transplantation, up to 5 years post-transplantation

• Total number of clinically significant biliary complications

  within 1 year post-transplantation, up to 5 years post-transplantation

• Incidence of biliary complications

  within 1 year post-transplantation, up to 5 years post-transplantation

Interventions

Endischemic hypothermic oxygenated machine perfusion (any device) 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) 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) 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) 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) 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) DEVICE

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

Static cold storage OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• Eligible MP protocols are:
• end-ischemic single- or dual hypothermic oxygenated MP \[e(D)HOPE\],
• end-ischemic (back-to-base) normothermic MP \[eNMP\],
• continuous (device-to-donor) normothermic MP \[cNMP\],
• e(D)HOPE followed by controlled oxygenated rewarming and normothermic MP \[e(D)HOPE-COR-NMP)\],
• e(D)HOPE followed by normothermic MP \[e(D)HOPE-NMP\], or
• Normothermic regional perfusion followed by SCS or an ex situ MP protocol.
• A minimum follow-up of 12 months after liver transplantation is required.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• A.O.U. Città della Salute e della Scienza: collaborator

Study Sites (2)

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

Torino, Italy

RECRUITING

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

RECRUITING

MeSH Terms

Conditions

End Stage Liver Disease; Liver Failure, Acute; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vincent E de Meijer, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabrina Stimmeder, MD

CONTACT

‭+31503612896‬; s.stimmeder@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 14, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 14, 2026

Record last verified: 2026-04

Locations

NL (1); IT (1)