Actively Recruiting

Age: 18Years +
All Genders
NCT07585890

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

Led by University Medical Center Groningen · Updated on 2026-05-14

10000

Participants Needed

2

Research Sites

245 weeks

Total Duration

On this page

Sponsors

U

University Medical Center Groningen

Lead Sponsor

A

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmortem donor livers accepted for transplantation in patients older than 18 years
  • All donor types included (donation after brain death or circulatory death)
  • Preservation using static cold storage alone or combined with machine perfusion
  • Donor livers underwent machine perfusion as part of routine clinical practice
  • Eligible machine perfusion protocols include end-ischemic hypothermic oxygenated MP, end-ischemic normothermic MP, continuous normothermic MP, hypothermic oxygenated MP followed by rewarming and normothermic MP, and normothermic regional perfusion followed by static cold storage or ex situ MP
  • Minimum follow-up of 12 months after liver transplantation required
Not Eligible

You will not qualify if you...

  • Livers assigned to machine perfusion as part of a randomized or interventional clinical trial
  • Living donor liver transplantation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

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

Torino, Italy

Actively Recruiting

2

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Actively Recruiting

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Research Team

S

Sabrina Stimmeder, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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