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Recruiting NCT05680246

Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Donor Livers (DHOPEPROLONG)

— Observational Liver Transplantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DHOPE-PRO.
Who it may be relevant to
Registry conditions: Liver Transplantation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Observational Study to Investigate Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Human Donor Livers (DHOPEPROLONG)

Overview

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

  • Device DHOPE-PRO
    Prolonged DHOPE preservation \>4 hours

Primary outcome measures

  • Death-censored graft survival [Time frame: Up to 5-years]
Secondary outcome measures (11)
  • Overall graft survival [Time frame: Up to 5-years]
  • overall patient survival [Time frame: Up to 5-years]
  • arterial and biliary complication-free survival (ABCFS) [Time frame: Up to 5-years]
  • incidence of biliary complications [Time frame: Up to 5-years]
  • incidence of vascular complications [Time frame: Up to 5-years]
  • incidence of acute cellular rejection [Time frame: Up to 5-years]
  • incidence of chronic rejection [Time frame: Up to 5-years]
  • incidence of re-transplantation [Time frame: Up to 5-years]
  • incidence of recurrence of primary disease [Time frame: Up to 5-years]
  • incidence of new-onset chronic kidney disease [Time frame: Up to 5-years]
  • incidence of new-onset diabetes after transplantation [Time frame: Up to 5-years]

Eligibility criteria

Inclusion criteria

  • Adult patients (>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic DHOPE for >4 hours

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • University Medical Center Groningen — Groningen

Identifiers

NCT: NCT05680246 · UMCG_DHOPE-PRO-LONG_2023/01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗