NCT05520320

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,202 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-08-24
• Primary completion: 2022-12-31
• Completion: 2023-08-01
• First posted: 2022-08-29
• Last updated: 2024-04-22

Locations

2 sites across 2 countries: Netherlands, Switzerland