NCT07585890From ClinicalTrials.govRecruiting

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

Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe (REFRAME-MP)

End-stage Liver Disease (ESLD)
Acute Liver Failure
Liver Cirrhosis
Liver Transplantation

At a glance

Phase: Phase not stated
Study type: Observational
Sponsor: University Medical Center Groningen
Enrolment target: 10,000
Started: 21 April 2026
Main results due: 31 December 2026
Study sites: 18
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

* 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:

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

Exclusion Criteria:

* 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(18)

Medical University of Innsbruck
Innsbruck, Austria
Recruiting
Medical University of Vienna
Vienna, Austria
Not yet recruiting
UZ Ghent
Ghent, Belgium
Not yet recruiting
University Hospitals Leuven
Leuven, Belgium
Not yet recruiting
CHU de Liège
Liège, Belgium
Not yet recruiting
Aachen University Hospital
Aachen, Germany
Not yet recruiting
University Hospital Essen
Essen, Germany
Recruiting
Frankfurt University Hospital
Frankfurt, Germany
Not yet recruiting
University Hospital Heidelberg
Heidelberg, Germany
Not yet recruiting
A.O.U. Città della Salute e della Scienza
Torino, Italy
Recruiting
University Medical Center Groningen
Groningen, Netherlands
Recruiting
Leiden University Medical Center
Leiden, Netherlands
Not yet recruiting
Karolinska Institutet
Stockholm, Sweden
Not yet recruiting
Bern University Hospital
Bern, Switzerland
Not yet recruiting
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Not yet recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Not yet recruiting
King's College Hospital NHS Foundation Trust
London, United Kingdom
Not yet recruiting
Royal Free London NHS Foundation Trust
London, United Kingdom
Not yet recruiting

Showing 18 of 18 sites. 4 of the 18 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07585890. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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