A French multicenter randomized controlled trial of hypothermic oxygenated perfusion in extended criteria donor liver transplantation.

The aim of this study was to assess the efficacy of end-ischemic hypothermic oxygenated perfusion (HOPE) used before liver transplantation (LT) with extended criteria donor (ECD) organs from donation after brain death (DBD) in reducing early allograft dysfunction (EAD) compared with static cold storage (SCS). Between 2019 and 2023, 262 ECD-DBD grafts from 8 French centers were randomly assigned for LT either after SCS (control group, n = 131) or after SCS and subsequent 1-4 h single portal HOPE before implantation (HOPE group, n = 131). The primary endpoint was the incidence of EAD. HOPE resulted in a significantly lower rate of EAD (17.6% vs 30.5%, P = .01). Severe complication rate (61.5% vs 52.4%, P = .15), comprehensive complication index (49 [34-65] vs 46 [35-65], P = .78), and 90-day mortality (5.3% vs 2.3%, P = .20) did not differ significantly between the control and HOPE groups, respectively. Four patients (4.9%) in the control group and 3 patients (3.3%) in the HOPE group experienced ischemic cholangiopathy at 1 year after LT (P = .71). In older patients receiving grafts with more than 6 hours of cold ischemia, HOPE was associated with a lower severe complication rate (26% vs72%, P = .005). HOPE in ECD grafts from DBD for LT reduces EAD with little clinical impact on morbidity and survival in recipients with low model for end-stage liver disease scores. Older recipients with long cold ischemia time might benefit the most. Clinical trial number: NCT03929523.