【Background】 Simple cold storage (SCS) is commonly used to preserve kidney allografts from deceased donors. Randomized clinical trials in Europe and the USA have demonstrated that hypothermic machine perfusion (HMP) improves transplantation outcomes. This study reports the first multicenter clinical trial of HMP in Japan, comparing contralateral kidneys preserved with SCS and HMP from the same donors.
【Methods】 Sixteen consecutive deceased donors provided kidneys for this study. One kidney from each donor was assigned to HMP, while the other was preserved using SCS. All 32 recipients were followed for one year. The primary endpoint was to assess stable perfusion parameters and conditions in the HMP group. Secondary endpoints included the duration of delayed graft function (DGF), incidence of primary graft non-function, serum creatinine levels, and allograft survival.
【Results】 All 16 HMP-preserved kidneys maintained stable perfusion and were successfully transplanted. Compared with the SCS group, HMP relatively reduced DGF duration (6.1±12.2 days vs. 3.4±4.8 days). Primary non-function occurred in one SCS recipient. Serum creatinine levels showed a lower tendency in the HMP group (e.g., 2.0±0.9 mg/dL vs. 11.7±0.7 mg/dL at one month). One-year graft survival was 100% in the HMP group, compared to 93.8% in the SCS group. All these data showed no significantly difference.
【Conclusion】 Hypothermic machine perfusion demonstrated safe use in a clinical setting and the possibility of reduced delayed graft function, improved allograft function, and superior one-year survival, However, further study will be needed.
