- Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe — Recruiting • Gastroenterology • NCT07585890.
- What is being tested: This study establishes a reference framework for outcomes following machine-preserved liver transplantation across Europe, addressing the clinical need for standardized outcome data across different machine perfusion modalities (normothermic, subnormothermic, and hypothermic) rather than conducting direct randomized comparisons.
- Patient eligibility overview: The trial includes adult liver transplant recipients across European centres using machine perfusion preservation; eligibility is broadly inclusive to capture real-world practice patterns, with graft selection often predetermined by donor characteristics and organ quality rather than random allocation to….
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.