Oxygenated versus standard cold perfusion preservation in kidney transplantation (COMPARE): a randomised, double-blind, paired, phase 3 trial.
Jochmans, I., et al.Lancet 2020; 396(10263): 1653-1662.
Aims
This study aimed to determine if supplemental oxygen during hypothermic machine perfusion (HMP) led to improvements in the outcome of kidneys donated following circulatory death.
Interventions
One kidney from each donor was randomised to either oxygenated hypothermic machine perfusion (HMPO2) or HMP without oxygenation.
Participants
197 kidney pairs were randomised.
Outcomes
The primary endpoint was the estimated glomerular filtration rate (eGFR) at 12 months post-transplant. The secondary endpoints included patient survival and graft survival up at 12 months, primary non function, delayed graft function, renal function according to CKD-EPI and MDRD equations, acute rejection and safety outcomes.
Follow-up
12 months
CET Conclusions
The well-designed, multicentre, double-blind, randomised controlled trial compared oxygenated hypothermic machine perfusion (HMP) with standard (non-oxygenated) HMP in kidney pairs from DCD donors aged 50 and over with sites in Belgium, The Netherlands and United Kingdom. Kidneys from each pair were randomised according to a computer-generated sequence. Blinding was ensured by using empty dummy oxygen bottles in the standard HMP arm and all health care professionals and transplant recipients were blinded to the allocation. The sample size calculation showed that 81 pairs were needed to provide 90% power to show an 8 ml/min/1.73m² difference in the primary outcome estimated GFR. The primary analysis, based on intention-to-treat and ony including only kidney pairs for which both grafts were functioning at 12 months, showed no significant difference in eGFR. A sensitivity analysis that accounted for failed grafts and patient death showed a significantly higher eGFR in the oxygenated group. Graft failure was significantly lower in the oxygenated HMP group as was the number of biopsy-proven rejection episodes. The authors conclude that oxygenated HMP has the potential to improve clinical outcomes and reduce health-care costs.
Data analysis
Strict intention-to-treat analysis
Trial registration
ISRCTN - 32967929