Transplant Trial Watch

Oxygenated End-Hypothermic Machine Perfusion in Expanded Criteria Donor Kidney Transplant: A Randomized Clinical Trial.

Husen, P., et al.

JAMA Surgery 2021 [record in progress].


Aims
This study aimed to determine whether short-term oxygenated hypothermic machine perfusion preservation (end-HMPO2) following static cold storage (SCS) was more effective in improving kidney transplant outcomes in expanded criteria donor kidneys retrieved from brain dead donors, compared to SCS alone.

Interventions
Patients were randomly assigned to either end-HMPO2 after SCS or SCS alone.

Participants
305 expanded criteria donor kidneys retrieved from brain dead donors.

Outcomes
The primary outcome was graft survival at 1 year posttransplant. The secondary outcomes were patient survival, primary nonfunction, delayed graft function, acute rejection and estimated glomerular filtration rate.

Follow-up
12 months

CET Conclusions
This good quality randomised, partially-blinded, controlled trial was conducted as part of the Consortium for organ preservation in Europe (COPE). The study compared kidneys from expanded criteria donors that underwent static cold storage (SCS) alone or SCS plus oxygenated hypothermic machine perfusion (end-HMPO2) after arrival in the recipient transplant centre. Kidneys were randomised on arrival at the recipient centre according to a computer-generated randomisation scheme using an online randomisation tool. A sample size analysis was based on data from a previous trial and showed that 262 kidneys were needed to detect an improvement in 1-year graft survival from 80% to 92%. The intention to treat analysis excluded kidneys that were randomised but not transplanted and consisted of 262 kidneys. Fourteen kidneys of the end-HMPO2 group were cold stored because machine perfusion was not possible and six kidneys received machine perfusion <2 hours for logistical reasons. One-year graft survival was similar between groups and the there were no statistically significant differences for any of the secondary outcomes, i.e. delayed graft function, primary nonfunction, estimated glomerular filtration rate, and acute rejection. The authors comment that as the 1-year graft survival rate in the control group exceeded the baseline assumption, the study is statistically underpowered.

Jadad score
3

Data analysis
Per protocol analysis

Allocation concealment
Yes

Trial registration
ISRCTN63852508

Funding source
Non-industry funded