Liver Transplantation
Conditions
Keywords
machine preservation, machine perfusion, donor organ preservation, hypothermic oxygenated machine perfusion, donor liver machine perfusion
Brief summary
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.
Detailed description
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).
Interventions
DEVICEDHOPE-PRO
Prolonged DHOPE preservation \>4 hours
Sponsors
University Medical Center Groningen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (\>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic DHOPE for \>4 hours
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death-censored graft survival | Up to 5-years | Death-censored graft survival, assessed by survival analysis methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall patient survival | Up to 5-years | overall patient survival, assessed by survival analysis methods. |
| arterial and biliary complication-free survival (ABCFS) | Up to 5-years | arterial and biliary complication-free survival (ABCFS), assessed by survival analysis methods. |
| incidence of biliary complications | Up to 5-years | incidence of biliary complications |
| incidence of vascular complications | Up to 5-years | incidence of vascular complications |
| incidence of acute cellular rejection | Up to 5-years | incidence of acute cellular rejection |
| Overall graft survival | Up to 5-years | Overall graft survival, assessed by survival analysis methods. |
| incidence of re-transplantation | Up to 5-years | incidence of re-transplantation |
| incidence of recurrence of primary disease | Up to 5-years | incidence of recurrence of primary disease (including recurrence of malignancies) |
| incidence of new-onset chronic kidney disease | Up to 5-years | incidence of new-onset chronic kidney disease |
| incidence of new-onset diabetes after transplantation | Up to 5-years | incidence of new-onset diabetes after transplantation |
| incidence of chronic rejection | Up to 5-years | incidence of chronic rejection |
Countries
Netherlands
Contacts
Primary ContactVincent E de Meijer, MD, PhD
Outcome results
None listed