MedTrace Logo

Long-term Outcomes After Hypothermic Oxygenated Machine Perfusion of Donor Livers Using Real-world Data

NCT05520320 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1202

Last updated 2024-04-22

No results posted yet for this study

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).

Conditions

  • Organ Preservation
  • Liver Transplantation
  • Hypothermic Machine Perfusion

Interventions

DEVICE

Hypothermic oxygenated machine perfusion (any device)

After static cold storage, all grafts included in this study are subjected to \>1 hour of hypothermic oxygenated machine perfusion at 4-12°C with an acellular perfusion solution.

Sponsors & Collaborators

  • University of Zurich

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Vincent E de Meijer, MD, PhD · University Medical Center Groningen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-24
Primary Completion
2022-12-31
Completion
2023-08-01

Countries

  • Netherlands
  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05520320 on ClinicalTrials.gov