Perfused Liver Utilisation Study (PLUS)
The Perfused Liver Utilisation Study (PLUS) follows on from the COPE liver perfusion study, and is designed to explore the effect of availability of Normothermic Machine Perfusion (NMP) on organ utilisation. The study is being run by the University of Oxford, and involves all seven UK liver transplant centres. It is funded by a grant from the NIHR i4i Challenge Awards, and supported by the NHSBT Clinical Trials Unit.
The study utilises a "threshold crossing" design to determine whether routine availability of NMP can improve functional utilisation (transplantation with one-year graft survival) of poorly-utilised livers compared to routine static cold storage. We aim to include 799 liver offers, which will be recruited by NHSBT Hub Operations at the time of offering. NMP will be made available to centres for these livers, and functional utilisation will be compared to a real-world historical control cohort with identical inclusion criteria to see if the pre-defined threshold for improved utilisation is met.
The study is currently in set-up, aiming to start recruitment in late 2021.