Sample size {14}
A sample size of 119 patients per randomized group (238 in total) is needed based on the following parameters:Expected decrease of EAD rate from 30% in the control group to 15% in the HOPE group (50% decrease of EAD based on previous preliminary clinical studies) [Alpha: 0.05Power: 0.80Two-sided testThe sample size was calculated using the “pwr.2p.test” function of R (R Foundation for Statistical Computing, Vienna, Austria), package “Pwr”. In order to take into account a 10% proportion of dropouts or patients who prematurely terminate the study, 133 patients shall be recruited per group, i.e., 266 patients in total. Because there is about 20% of dropouts on the waiting list in France (2017 annual report of the “Agence de la Biomédecine”), and about 50% of liver grafts are provided from ECD, it is expected that 660 patients should be included in the study to be able to randomize 266 patients. In order not to slow down randomizations as they approach the total needed, inclusions will be possible beyond 660 patients within the limit of 1000 patients included.According to EUROTRANSPLANT and the “Agence de la Biomédecine”, 50% of liver grafts are provided from ECD with the rate increasing over recent years. To be on the safe side, we expect that centers may randomize half of their potential transplanted patients with ECD, namely 25% of their total number of liver transplantations a year.