Clinical trial NCT05520320: Long-term Outcomes After Hypothermic Oxygenated Machine Perfusion of Donor Livers Using Real-world Data
Official title: Assessment of Long-term Outcomes After Transplantation of Donor Livers Preserved by Hypothermic Oxygenated Machine Perfusion (HOPE): a Retrospective Cohort Analysis of Real-world Data (IDEAL-D Stage 4)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Organ Preservation
Liver Transplantation
Hypothermic Machine Perfusion
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2022-08-29
Enrollment: 1202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (\>18 years) undergoing liver transplantation of donor livers preserved with end-ischemic HOPE.

Brief summary: End-ischemic hypothermic oxygenated machine perfusion (HOPE) 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. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), with several published randomized controlled trials on short-to-medium term outcomes, scientific evidence for HOPE has currently reached stage 3. Assessment of long-term outcomes after HOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking. Therefore, we aim to conduct an international, multi-center, retrospective, observational cohort study to assess long-term outcomes after transplantation of donor livers preserved by hypothermic oxygenated machine perfusion (HOPE).


Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic HOPE (including donation after normothermic regional perfusion) between 01.01.2012 and 31.12.2021.

Exclusion Criteria:

* Simultaneous multiorgan transplantations, sequential normothermic machine perfusion (e.g., DHOPE-COR-NMP, but not NRP), living partial liver donation.

Primary outcomes:
measure: Death-censored graft survival, assessed by survival analysis methods
timeFrame: Up to 5-years
Secondary outcomes:
measure: Overall graft survival
timeFrame: Up to 5-years
measure: Overall patient survival
timeFrame: Up to 5-years
measure: Arterial and biliary complication-free survival (ABCFS)
timeFrame: Up to 5-years
measure: Incidence of biliary complications
timeFrame: Up to 5-years
measure: Incidence of vascular complications
timeFrame: Up to 5-years
measure: Incidence of acute cellular rejection
timeFrame: Up to 5-years
measure: Incidence of chronic rejection
timeFrame: Up to 5-years
measure: Incidence of re-transplantation
timeFrame: Up to 5-years
measure: Incidence of recurrence of primary disease (including recurrence of malignancies)
timeFrame: Up to 5-years
measure: Incidence of new-onset chronic kidney disease
timeFrame: Up to 5-years
measure: Incidence of new-onset diabetes after transplantation
timeFrame: Up to 5-years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: University Medical Center Groningen
name: Vincent E de Meijer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: