End-ischemic dual hypothermic oxygenated machine perfusion (DHOPE) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary complications, when compared with static cold storage. End-ischemic DHOPE can be used to prolong donor liver preservation time for up to 24 hours. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), scientific evidence for prolonged DHOPE has currently reached stage 3. Assessment of long-term outcomes after prolonged DHOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking.
The aim of this study is to assess long-term outcomes after transplantation of donor livers preserved by prolonged hypothermic oxygenated machine perfusion (DHOPE-PRO).
Study Type
OBSERVATIONAL
Enrollment
500
Prolonged DHOPE preservation \>4 hours
University Medical Center Groningen
Groningen, Netherlands
RECRUITINGDeath-censored graft survival
Death-censored graft survival, assessed by survival analysis methods.
Time frame: Up to 5-years
Overall graft survival
Overall graft survival, assessed by survival analysis methods.
Time frame: Up to 5-years
overall patient survival
overall patient survival, assessed by survival analysis methods.
Time frame: Up to 5-years
arterial and biliary complication-free survival (ABCFS)
arterial and biliary complication-free survival (ABCFS), assessed by survival analysis methods.
Time frame: Up to 5-years
incidence of biliary complications
incidence of biliary complications
Time frame: Up to 5-years
incidence of vascular complications
incidence of vascular complications
Time frame: Up to 5-years
incidence of acute cellular rejection
incidence of acute cellular rejection
Time frame: Up to 5-years
incidence of chronic rejection
incidence of chronic rejection
Time frame: Up to 5-years
incidence of re-transplantation
incidence of re-transplantation
Time frame: Up to 5-years
incidence of recurrence of primary disease
incidence of recurrence of primary disease (including recurrence of malignancies)
Time frame: Up to 5-years
incidence of new-onset chronic kidney disease
incidence of new-onset chronic kidney disease
Time frame: Up to 5-years
incidence of new-onset diabetes after transplantation
incidence of new-onset diabetes after transplantation
Time frame: Up to 5-years
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