CONSORT diagram.
COLD, RECRUITMENT
Two eligibility periods are presented due to the COVID-19 pandemic: 4 September 2020 is the date the trial officially closed to recruitment, and 23 March 2020 was the start of the UK national lockdown. No participants were recruited between 23 March 2020 and 4 September 2020. Two participants did not have a cold ischemic time (CIT) reported, and two participants received dual transplants and, hence, do not have a left/right kidney variable populated; these four cases were excluded from all risk-adjusted modeling. **Two additional exclusion criteria (donors who underwent normothermic regional perfusion or one of a pair already randomized as a single kidney in the trial) were introduced on 13 October 2017, and, retrospectively, two participants fulfilled these exclusion criteria (both were randomized to NMP). These patients were included in the MITT analysis and excluded from the per-protocol analysis.In total, 168 kidneys were allocated to SCS and 170 to NMP. In the SCS arm, one kidney received NMP due to the surgeon’s preference. In the NMP arm, 25 kidneys did not receive NMP. In 14 cases, this was due to the inability to secure a cannula into or around the renal artery; in eight cases, this was due to logistics with access to theater or time constraints; in one case, this was due to the surgeon’s preference; in one case, this was due to damage to the renal artery; and in one case, the kidney was transplanted as a dual transplant. A total of 21 kidneys in the SCS arm and 27 kidneys in the NMP arm were not transplanted (details are listed in Fig. There were no withdrawals from the trial. Two participants were randomized in error, as the single kidneys were transplanted as dual kidney transplants. Fifty-five participants experienced a protocol deviation: not receiving the randomized treatment was the most common reason (previously described); 21 kidneys that were one of a pair in the trial that were transplanted in the incorrect order to which they were randomized (due to logistics); and 13 kidneys that were randomized to NMP did not receive 60 min of NMP. All of the participants who experienced a protocol deviation were included in the modified intention-to-treat (MITT) analysis but were excluded from the per-protocol analysis. Four cases had to be excluded from all risk-adjusted modeling, as one of the risk adjustment factors was missing (two participants did not have a cold ischemic time reported, and two participants who received dual transplants did not have a left/right kidney variable populated) (Fig. Two interim analyses were carried out, and the DMC recommended continuation after both (