Secondary endpoints
post-reperfusion syndrome, extrahepatic biliary complications, reperfusion injuriesLiver injury, ischemia, blood transfusions, cholestasis
GRAFT LOSS, ISCHEMIA, POSTOPERATIVE COMPLICATION, COMPLICATION, CHOLESTASIS

Quality of conservationDosage during perfusion by the HOPE machine (AST, ALT, LDH, hyaluronic acid, lactate levels in machine perfusate at 30 min and at the end of the perfusion)Additional 3 mL of machine perfusate will be sampled at 30 min and at the end of machine perfusion and stored at − 80 °C. Those samples will be used in case of future unexpected research about machine perfusate compoundsDifference between the two treatment arms in the proportion of patients with ischemia–reperfusion injuriesLiver injury assessed by serum AST and ALT at 6 h (± 2 h), 12 h (± 2 h) and every day until POD7 after transplantationPost-reperfusion liver biopsy (histological changes, level of necrosis)Untargeted liver graft metabolic profiling (by high-resolution nuclear magnetic resonance—1H HR-NMR spectrometer) on liver biopsies on the back-table in both study groups and immediately after liver perfusion in the HOPE group. This test will be centralized in the Strasbourg centerDifference between the two treatment arms in the proportion of patients with intra-operative eventsIntra-operative blood transfusions (red blood cells, fresh frozen plasma, thrombocyte concentrate)Occurrence of post-reperfusion syndrome, defined as a 50% decrease in median arterial pressure during the 5 min following the graft revascularizationDuration of surgery Postoperative outcome (liver function tests not included in the definition of EAD)Difference in means between the two treatment arms for:
Recipient blood level of factor V at 6 h (± 2 h), 12 h (± 2 h) and every day until POD7Arterial lactates at 6 h (± 2 h), 12 h (± 2 h) and every day until discharge from intensive care (and maximum until POD7)MEAF score (0–10) at POD3, including POD3 bilirubin, ALT max, and INR max at POD3. This score will be compared with the Olthoff’s definition of EAD and the L-GrAFT risk factorL-GrAFT risk factor (− 6 to + 6) including AST, INR, total bilirubin, and platelets every day until POD 10. This score will be compared with both MEAF score and Olthoff’s scoreKidney function testsDaily serum creatinine level during the first 7 PODsDaily glomerular filtration rate (assessed using MDRD and CKD-EPI) during the first 7 PODsDifference between the two treatment arms in the proportion of patients requiring renal dialysis within the first 7 PODs90-day morbidity and mortalityDifference between the two treatment arms in the proportion of patients with severe postoperative complication (defined as Dindo–Clavien classification ≥ 3) occurring before day 90 post surgeryDifference in means between the two treatment arms of the comprehensive complication index (CCI) [Difference between the two treatment arms in the proportion of patients who were deceased before day 90 after surgeryDifference in means between the two treatment arms of the length of intermediate care unit stay and total hospital stayDifference between the two treatment arms in the proportion of patients with intra- and extrahepatic biliary complications within the first year after liver transplantation, assessed by:Serum cholestasis parameter (bilirubin, gammaLiver contrast-enhanced MRI, including a magnetic resonance cholangiopancreatography (MRCP), 12 months after liver transplantation (except for patients who underwent a re-transplantation during the study)Actuarial graft and patient’s survival rates at 3 months and 1 yearDifference between the two treatment arms in the proportion of patients without graft loss at 3 months and 1 year.Difference between the two treatment arms in the proportion of patients alive at 3 months and 1 year.Costs of liver transplantation with ECD grafts using HOPE or not, incremental cost-effectiveness ratio at 12 months post-surgery. Details about the cost-effectiveness analysis are given in Supplementary Material 