NCT07585890 Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
| NCT ID | NCT07585890 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | End-stage Liver Disease (ESLD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2026-04-21 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2026-04-21 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Vincent E de Meijer, MD, PhD
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT07585890 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying End-stage Liver Disease (ESLD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07585890 currently recruiting?
Yes, NCT07585890 is actively recruiting participants. Contact the research team at s.stimmeder@umcg.nl for enrollment information.
Where is the NCT07585890 trial being conducted?
This trial is being conducted at Torino, Italy, Groningen, Netherlands.
Who is sponsoring the NCT07585890 clinical trial?
NCT07585890 is sponsored by University Medical Center Groningen. The principal investigator is Vincent E de Meijer, MD, PhD at University Medical Center Groningen. The trial plans to enroll 10,000 participants.