Actively Recruiting
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe (REFRAME-MP)
Led by University Medical Center Groningen · Updated on 2026-05-14
10000
Participants Needed
2
Research Sites
208 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
Researchers are establishing a reference framework to understand outcomes in liver transplantation using machine perfusion (MP), a technology now routinely used to preserve donor livers. The study aims to update existing risk scores and benchmarks that were developed before the widespread use of MP, reflecting the current clinical practice and the best achievable results across various MP methods. This observational study will collect real-world data to better characterize survival and complications after liver transplantation. The study observes liver transplants preserved by different machine perfusion methods, including end-ischemic hypothermic oxygenated MP, normothermic MP in various forms, and combinations such as HOPE-COR-NMP and HOPE-NMP. It also includes preservation by static cold storage alone. The choice of perfusion protocol is based on standard institutional practices, covering various donor types and perfusion devices. Participants are followed for a minimum of 12 months post-transplantation. Participants will be monitored for outcomes including graft survival, patient survival, liver-related complications, rejection episodes, recurrence of primary disease, and kidney injury over periods ranging from 1 week to 5 years after transplant. Data will also be collected on patient recovery and healthcare use within the first year. This comprehensive follow-up involves actuarial survival analysis and tracking of complications to understand the effectiveness and risks associated with each preservation method.
CONDITIONS
Brief Title
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older at the time of liver transplantation
- All postmortal donor livers accepted, transplanted or not, after machine perfusion
- All donor types included, both donation after brain death (DBD) and donation after circulatory death (DCD)
- Preservation with static cold storage alone or combined with machine perfusion
- Donor livers must have undergone 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, HOPE-COR-NMP, HOPE-NMP, and normothermic regional perfusion with static cold storage or ex situ MP
- Minimum follow-up of 12 months after liver transplantation required
You will not qualify if you...
- Livers allocated to a machine perfusion protocol as part of a prospective randomized or interventional clinical trial
- Living donor liver transplantation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies based on preservation and transplantation timing
Participants undergo machine perfusion of donor livers using different device-based preservation techniques as part of routine clinical practice.
1 visit around the time of transplantation
Duration - At least 12 months following transplantation
Participants are monitored for liver transplant outcomes, complications, and recovery for at least 12 months after transplantation.
Approximately monthly visits during the first year post-transplant
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
Research Team
S
Sabrina Stimmeder, MD
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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