End-ischemic hypothermic oxygenated perfusion for extended criteria donors in liver transplantation: a multicenter, randomized controlled trial-HOPExt.
Pradat, P., et al.Trials [Electronic Resource] 2023; 24(1): 379.
Aims
This is a protocol for a randomised controlled trial that aims to determine the efficacy of hypothermic oxygenated machine perfusion (HOPE) when used prior to transplantation of extended criteria donor (ECD) liver grafts obtained from brain-dead donors, for reduction of early allograft dysfunction (EAD) post-operation in comparison to simple cold static storage.
Interventions
ECD liver grafts will be randomly assigned to receive either HOPE or static cold storage.
Participants
Adult patients (≥ 18 years) transplanted with a liver graft harvested from a brain-dead ECD.
Outcomes
The primary outcomes are early allograft dysfunction (EAD) and primary non-function (PNF). The secondary outcomes include quality of conservation; ischemia–reperfusion injuries, intra-operative events; 90-day morbidity and mortality; duration of intermediate care unit stay and total hospital stay; actuarial graft and patient’s survival rates; and costs of liver transplantation with ECD grafts using HOPE or not and incremental cost-effectiveness ratio.
Follow-up
12 months (± 30 days) following transplantation (36 months maximum).
CET Conclusions
This paper documents in detail the study protocol for a trial of end-ischaemic hypothermic oxygenated machine perfusion (HOPE) in extended criteria donor livers. There is a pragmatic element to the design, as livers will be preserved by static cold storage and then in the study group will receive 1-4 hours of HOPE. By concentrating on ECD livers, the study is more likely to find a significant impact on the primary outcome of early allograft dysfunction. The study is powered (80%) for a reduction in early allograft dysfunction from 30% to 15%, accounting for 10% dropout rate. Randomization will occur after allocation of the liver graft to a recipient. Allocation concealment is maintained, but there is no blinding of the surgical team nor patient. Data analysts will be blinded to group allocation. Interestingly the trial commenced in 2019 and is ongoing. This paper is published in order to “prevent biased analysis of trial outcomes and improve transparency of the trial results”. The study is funded by the French Ministry of Health and is being conducted at 8 transplant centres in France.
Trial registration
ClinicalTrials.gov - NCT03929523