Why a trial on machine perfusion ?

Organ shortage remains a major challenge in orthotopic liver transplantation (OLT). Multiple approaches for donor pool expansion are being pursued concurrently. These include the use of living donors, splitting of cadaveric livers for two recipients, and the use of ECD-allografts for OLT. ECD-allografts, however, exhibit poor tolerance to ischemia-reperfusion injury, an important factor in liver damage.

In recent years, several strategies have been developed aiming at reconditioning poor quality ECD-allografts. HOPE has been tested intensively in pre-clinical animal experiments and its positive effects have been demonstrated among others to reduce the incidence of biliary complications, mitochondrial damage and improve cellular energy-status. Graft reconditioning using HOPE has recently shown beneficial effects in a Swiss cohort of patients in donation after cardiac death (DCD) transplantation. In donation after brain death, which is the most frequent source of ECD-allografts in Europe, clinical evidence for HOPE is lacking.

HOPE-ECD-DBD is an investigator initiated, open-label, phase-II, prospective multicenter randomized controlled trial on the effects of HOPE on ECD-allografts in donation after brain death (DBD) OLT (HOPE-ECD-DBD). The present trial aims to deliver level-I evidence in DBD liver transplantation using HOPE-reconditioned ECD-allografts. Recruitment for the HOPE-ECD-DBD Trial was initiated in August 2017. First results are expected in 2018.

HOPE ECD-DBD is supported by federal and local research funds of the RWTH Aachen University. The study is performed at four major European Liver Transplantation Centers (University Hospital RWTH Aachen, Germany; University of Ghent, Belgium; University of Bucharest, Romania; University of Prague; Czech Republic) and is currently recruiting at 2 sites.