Comparing Liver Transplant Outcomes With and Without Graft Recooling After Normothermic Machine Perfusion to Reduce Early Graft Dysfunction

What this Trial Is About

The trial investigates liver transplantation outcomes by comparing two methods of graft implantation following normothermic machine perfusion NMP. It aims to determine whether avoiding graft recooling before implantation reduces early graft dysfunction and improves early post-transplant results. The study focuses on adult recipients of deceased-donor liver grafts preserved with NMP or sequential hypothermic-normothermic machine perfusion SHNMP. Participants are randomly assigned to one of two groups the intervention group receives liver grafts implanted without recooling, using a room-temperature 5% albumin flush immediately before reperfusion, while the control group undergoes the standard procedure involving recooling with a cold preservation solution flush before implantation. This is an open-label, parallel-group trial conducted at multiple centers. Participants will be monitored and followed for 90 days after transplantation. Researchers will assess the incidence of Early Allograft Dysfunction EAD within seven days post-transplant, as defined by the Olthoff criteria. Secondary outcomes include evaluation of ischemia-reperfusion injury, vascular and biliary complications, survival rates, hospital stay length, transfusion needs, and safety. The study involves clinical assessments and monitoring throughout the follow-up period to evaluate graft and patient outcomes.

Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation