Pilot, open, randomized, prospective trial for normothermic machine perfusion evaluation in liver transplantation from older brain death donors.
Ghinolfi D, Rreka E, et al.Liver Transpl. 2018; [record in progress].
Aims
To determine whether ex-situ normothermic machine perfusion (NMP) might minimize ischemia/reperfusion injury (IRI) of liver grafts.
Interventions
Patients randomized (1:1) to NMP or cold storage.
Participants
20 adult primary whole-size liver transplant recipients of older liver grafts (≥70 years) from brain death donors.
Outcomes
The primary study endpoint was graft and patient survival at 6 months post transplantation. The secondary endpoints were to IRI (by means of peak transaminases within 7 days after surgery), incidence of biliary complications at Month 6, and evaluation of liver and bile duct histology.
Follow-up
6 months post transplantation.
CET Conclusions
This small pilot study investigates the use of post SCS normothermic perfusion in livers from elderly (>70 years) donors. Whilst the study finds no difference in clinical outcomes, there was a reduction in histological markers of ischaemia-reperfusion injury in the NMP preserved livers. The lack of improvement in clinical outcomes differs from the recent, larger multicentre COPE study, which found improved early biochemical markers and a reduction in reperfusion instability with longer periods of NMP. The authors postulate that this may be due to the older donor population, which is possible, although it should also be noted that these were all DBD (no DCD) livers, and the perfusion device used is different. Ultimately, this study is underpowered to demonstrate differences in clinical efficacy with just 10 patients per arm.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT02940600