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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Transplantation
• Intervention / Treatment: Device: DHOPE-PRO

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Vincent E de Meijer, MD, PhD; Phone Number: +31503616161; Email: v.e.de.meijer@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GZ
    • Recruiting
    • University Medical Center Groningen
    • Principal Investigator: Vincent E de Meijer, MD, PhD
    • Contact: Vincent E de Meijer, MD, PhD; Phone Number: +31503616161; Email: v.e.de.meijer@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult liver transplant recipients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DHOPE-PRO; Outcomes of recipients who underwent liver transplantation of donor organs that were perfused with prolonged (>4 hours) DHOPE.	Device: DHOPE-PRO; Prolonged DHOPE preservation >4 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death-censored graft survival	Death-censored graft survival, assessed by survival analysis methods.	Up to 5-years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall graft survival	Overall graft survival, assessed by survival analysis methods.	Up to 5-years
overall patient survival	overall patient survival, assessed by survival analysis methods.	Up to 5-years
arterial and biliary complication-free survival (ABCFS)	arterial and biliary complication-free survival (ABCFS), assessed by survival analysis methods.	Up to 5-years
incidence of biliary complications	incidence of biliary complications	Up to 5-years
incidence of vascular complications	incidence of vascular complications	Up to 5-years
incidence of acute cellular rejection	incidence of acute cellular rejection	Up to 5-years
incidence of chronic rejection	incidence of chronic rejection	Up to 5-years
incidence of re-transplantation	incidence of re-transplantation	Up to 5-years
incidence of recurrence of primary disease	incidence of recurrence of primary disease (including recurrence of malignancies)	Up to 5-years
incidence of new-onset chronic kidney disease	incidence of new-onset chronic kidney disease	Up to 5-years
incidence of new-onset diabetes after transplantation	incidence of new-onset diabetes after transplantation	Up to 5-years

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Vincent E de Meijer, MD, PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2033

Study Registration Dates

• First Submitted: December 25, 2022
• First Submitted That Met QC Criteria: December 25, 2022
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 19, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: machine perfusion; machine preservation; donor organ preservation; hypothermic oxygenated machine perfusion; donor liver machine perfusion
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: UMCG_DHOPE-PRO-LONG_2023/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD may be shared upon reasonable request, only with appreciation of the national and local institute's privacy regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No