HEMO(2)life (R) improves renal function independent of cold ischemia time in kidney recipients: A comparison with a large multicenter prospective cohort study

Background M101 is an extracellular hemoglobin isolated from a marine lugworm and is present in the medical device HEMO(2)life (R). The clinical investigation OXYOP was a paired kidney analysis (n = 60) designed to evaluate the safety and performance of HEMO(2)life (R) used as an additive to preservation solution in renal transplantation. The secondary efficacy endpoints showed less delayed graft function (DGF) and better renal function in the HEMO(2)life (R) group but due to the study design cold ischemia time (CIT) was longer in the contralateral kidneys. Methods An additional analysis was conducted including OXYOP patients and patients from the ASTRE database (n = 6584) to verify that the decrease in DGF rates observed in the HEMO(2)life (R) group may not be due solely to the shorter CIT but also to HEMO(2)life (R) performance. Kaplan-Meier estimate curves of cumulative probability of achieving a creatinine level below 250 mu mol/L were generated and compared in both groups. A Cox model was used to test the effect of the explanatory variables (use of HEMO(2)life (R) and CIT). Finally, a bootstrap strategy was used to randomly select smaller samples of patients and test them for statistical comparison in the ASTRE database. Results Kaplan-Meier estimate curves confirmed the existence of a relation between DGF and CIT and Cox analysis showed a benefit in the HEMO(2)life (R) group regardless of the associated CIT. Boostrap analysis confirmed these results. Conclusions The present study suggested that the better recovery of renal function observed among kidneys preserved with HEMO(2)life (R) in the OXYOP study is a therapeutic benefit of this breakthrough innovative medical device.