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

Recruiting

• Conditions: Liver Transplantation
• Interventions: Device: DHOPE-PRO

• Registration Number: NCT05680246
• Lead Sponsor: University Medical Center Groningen

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).

Study Timeline

• Study First Submitted: 2022-12-25
• Study First Submitted QC: 2022-12-25
• Study Start: 2023-01-01
• Study First Posted: 2023-01-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-19
• Last Update Posted: 2024-05-21
• Primary Completion: 2028-12
• Study Completion: 2033-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DHOPE-PRO	DHOPE-PRO	Outcomes of recipients who underwent liver transplantation of donor organs that were perfused with prolonged (\>4 hours) DHOPE.

Primary Outcome Measures

Name	Time	Method
Death-censored graft survival	Up to 5-years	Death-censored graft survival, assessed by survival analysis methods.

Secondary Outcome Measures

Name	Time	Method
overall patient survival	Up to 5-years	overall patient survival, assessed by survival analysis methods.
incidence of acute cellular rejection	Up to 5-years	incidence of acute cellular rejection
incidence of chronic rejection	Up to 5-years	incidence of chronic rejection
incidence of re-transplantation	Up to 5-years	incidence of re-transplantation
Overall graft survival	Up to 5-years	Overall graft 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 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

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands