Transplant Trial Watch

Hypothermic Oxygenated Machine Perfusion (HOPE) Reduces Early Allograft Injury and Improves Post-Transplant Outcomes in Extended Criteria Donation (ECD) Liver Transplantation from Donation After Brain Death (DBD): Results from a Multicenter Randomized Controlled Trial (HOPE ECD-DBD).

Czigany, Z., et al.

Annals of Surgery 2021 [record in progress]


Aims
This study aimed to investigate peak serum alanine aminotransferase (ALT) and postoperative clinical outcomes following hypothermic oxygenated machine perfusion (HOPE) compared to static cold storage (SCS) in extended criteria donation (ECD) after brain death (DBD) liver transplantation (LT).

Interventions
Participants were randomised to either the HOPE group or the SCS group.

Participants
46 adult patients (>18 years) listed for LT and fulfilling the predefined ECD-criteria.

Outcomes
The primary outcome was the difference in early allograft injury between the two treatment groups. The secondary outcomes were the incidence of post-transplant complications; further serum laboratory parameters; early allograft dysfunction (EAD); duration of intensive care unit (ICU) stay; duration of hospital stay; one-year patient and graft survival; and the analysis of serum, bile, tissue and perfusate biomarkers of ischemia-reperfusion injury (IRI).

Follow-up
1 year

CET Conclusions
This is a well conducted and well reported clinical trial in liver transplantation. Livers were randomised to static cold storage or to hypothermic oxygenation machine perfusion (HOPE). The study found clear evidence of reduced peak in AST in the first 7 days, by almost 50%. Preservation with HOPE was also associated with reduced hospital and ICU stay as well as reduced major complications. There was a trend towards improved early allograft dysfunction as well, but the study was underpowered to demonstrate this outcome, and in a larger study it may have been statistically significant. The study was conducted using extended criteria livers from DBD only, and potentially this allowed an effect to be demonstrated that may not be so apparent with standard criteria livers. Blinding of clinicians involved in the study was not feasible, which is understandable given the nature of the intervention. The study demonstrates significant clinical beneficial effects of HOPE in liver transplantation.

Jadad score
3

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Trial registration
ClinicalTrials.gov - NCT03124641

Funding source
Non-industry funded