Pilot, Open, Prospective, Randomized, Multicenter Trial on Quality Assessment of Declined Liver Grafts by Normothermic Ex Vivo Machine Perfusion to Reduce Time to Transplantation

What this Trial Is About

This research aims to evaluate whether normothermic machine perfusion (NMP) can safely increase the number of usable donor livers for transplantation, helping patients get transplants faster and improving outcomes. The study focuses on patients waiting for a liver transplant with a ReMELD-Na-Score of 21 or less, who do not meet certain special exception criteria. It investigates if this new assessment method reduces waiting time and improves survival and health after transplant. Participants are randomly assigned to one of two groups. The experimental group may receive livers initially declined by all German transplant centers but deemed suitable after at least four hours of NMP quality assessment. The control group receives livers through the usual transplant process. Declined livers are selected based on specific quality criteria such as steatosis less than 60%, fibrosis grade up to F3, and graft weight between 1 and 2.5 kg. During the study, researchers track how quickly participants receive a transplant as the main outcome. They also monitor survival rates, disease progression, recovery on the waitlist, quality of life, graft utilization, hospital stay costs, and complications up to 24 months after randomization. Participants will be followed for up to 12 months to observe transplant timing and up to 24 months for longer-term outcomes.

Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time