This abstract presents results from a U.S. pivotal multicenter RCT evaluating early allograft dysfunction (EAD) as a primary outcome in liver transplant clinical trials, using data from the Bridge to HOPE trial comparing HOPE and SCS preservation for extended-risk donor livers. The analysis demonstrates that EAD, measured by Olthoff Criteria, correlates strongly with clinically relevant transplant outcomes including hospital length of stay, biliary complications requiring intervention, biopsy-proven rejection, and adverse events. Reduced EAD rates with HOPE were statistically significant, and EAD proved to be a reliable surrogate marker for post-transplant morbidity and outcomes
Reich D, Schlegel A, Mao S, Hashimoto K, Nassar A, Foley D, Florman S, DeVera M, Pinna A, Chapman W, Bohorquez H, Roll G, Mihaylov P, Kubal C, Saharia A, Akoad M, Melcher M, Merani S. Early Allograft Dysfunction As A Clinical Trial Primary Outcome Measure Correlates With Later Outcomes: Analysis From A US Pivotal Multicenter Medical Device Trial Of Hypothermic Oxygenated Perfusion For Liver Transplant. Presented at: American Transplant Congress; June 2-5, 2024; Philadelphia, PA
