Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07585890 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: REFRAME-MP
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 25 → 30 locations Trial sites expanded: 19 → 25 locations Show 1 more changeShow less
    • Trial sites expanded: 19 → 25 locations
  2. Study sites: 19 to 25
  3. Trial sites expanded: 11 → 18 locations
  4. Study sites: 11 to 18
  5. Study sites: 10 to 11 Eligibility criteria expanded, about 14 words · Secondary endpoints: details revised at 4 of 13 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 4 of 13 entries
  6. Study sites: 9 to 10v3
  7. Trial sites expanded: 2 → 9 locationsv2
  8. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07585890
Lead Sponsor University Medical Center Groningen
Collaborators: A.O.U. Città della Salute e della Scienza
Conditions End-stage Liver Disease (ESLD), Acute Liver Failure, Liver Cirrhosis, Liver Transplantation
Enrollment 10,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov