A multicenter randomized-controlled trial of hypothermic oxygenated perfusion (HOPE) for human liver grafts before transplantation
Abstract
BACKGROUND & AIMS
Machine perfusion is a novel method intended to optimize livers before transplantation. Its effect, however, on morbidity within a one-year period after transplantation has remained unclear.
METHODS
In this multicenter controlled trial, we randomly assigned livers donated after brain death (DBD) for liver transplantation (LT). Livers were either conventionally cold stored (control-group), or cold stored and subsequently treated by 1-2h hypothermic oxygenated perfusion (HOPE) before implantation (HOPE-group). The primary endpoint was the occurrence of at least one post-transplant complication per patient, graded by the Clavien score of ≥III, within 1-year after LT. The comprehensive complication index (CCI®), laboratory parameters, as well as duration of hospital- and ICU-stay, graft survival, patient survival, and biliary complications served as secondary endpoints.
RESULTS
Between April 2015 and August 2019, we randomized 177 livers, resulting in 170 liver transplantations (85 in the HOPE-group and 85 in the control-group). The number of patients with at least one Clavien ≥III complication was 46/85 (54.1%) in the control-group, and 44/85 (51.8%) in the HOPE-group (odds ratio 0.91; 95%CI:0.50-1.66, p=0.76). Secondary endpoints were also not significantly different between groups. A post hoc analysis revealed however, that liver related Clavien ≥IIIb complications occurred less frequently in the HOPE- compared to the control-group (risk ratio 0.26;…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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