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

NCT ID: NCT05680246

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2033-12-31

Brief Summary

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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

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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).

Conditions

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Liver Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DHOPE-PRO

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

DHOPE-PRO

Intervention Type DEVICE

Prolonged DHOPE preservation \>4 hours

Interventions

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DHOPE-PRO

Prolonged DHOPE preservation \>4 hours

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent E de Meijer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Vincent E de Meijer, MD, PhD

Role: CONTACT

+31503616161

Facility Contacts

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Vincent E de Meijer, MD, PhD

Role: primary

+31503616161

Other Identifiers

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UMCG_DHOPE-PRO-LONG_2023/01

Identifier Type: -

Identifier Source: org_study_id

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