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

Key facts

Who runs it
University Medical Center Groningen
Where
Stockholm, SwedenSee the siteAlso in 9 other countries, 43 sites
Trial code
Status
Recruiting
People taking part
10,000 people, planned
Started
21 Apr 2026
Expected to end
31 Dec 2030
Type of study
Observational
Treatments tested
  • Endischemic hypothermic oxygenated machine perfusion (any device)
  • Endischemic (back-to-base) normothermic machine perfusion (any device)
  • Continuous (device-to-donor) normothermic machine perfusion (any device)
  • Endischemic HOPE-COR-NMP (any device)
  • Endischemic HOPE-NMP (any device)
  • Normothermic regional perfusion (any device)
  • Static cold storage
Record updated
12 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Living donor liver transplantation
  • 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

Where in Sweden

Also in 9 other countries, 43 sites

  • Karolinska InstitutetStockholm, SwedenContact: Gabriel Oniscu, MD, PhDNot yet recruiting

About the trial

What the trial wants to find out

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.

Treatments tested

  • Endischemic hypothermic oxygenated machine perfusion (any device)
  • Endischemic (back-to-base) normothermic machine perfusion (any device)
  • Continuous (device-to-donor) normothermic machine perfusion (any device)
  • Endischemic HOPE-COR-NMP (any device)
  • Endischemic HOPE-NMP (any device)
  • Normothermic regional perfusion (any device)
  • Static cold storage

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe (REFRAME-MP)
Record updated
12 November 2026