NCT05520320

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

August 25, 2022

Last Update Submit

April 19, 2024

Conditions

Organ PreservationLiver TransplantationHypothermic Machine Perfusion

Outcome Measures

Primary Outcomes (1)

  • Death-censored graft survival, assessed by survival analysis methods

    Defined as time from liver transplantation until re-transplantation or death due to graft dysfunction

    Up to 5-years

Secondary Outcomes (11)

  • Overall graft survival

    Up to 5-years

  • Overall patient survival

    Up to 5-years

  • Arterial and biliary complication-free survival (ABCFS)

    Up to 5-years

  • Incidence of biliary complications

    Up to 5-years

  • Incidence of vascular complications

    Up to 5-years

  • +6 more secondary outcomes

Interventions

Hypothermic oxygenated machine perfusion (any device)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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (\>18 years) undergoing liver transplantation of donor livers preserved with end-ischemic HOPE.

You may qualify if:

  • Adult patients (\>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic HOPE (including donation after normothermic regional perfusion) between 01.01.2012 and 31.12.2021.

You may not qualify if:

  • Simultaneous multiorgan transplantations, sequential normothermic machine perfusion (e.g., DHOPE-COR-NMP, but not NRP), living partial liver donation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Medical Center Groningen

Groningen, Netherlands

Location

University Hospital Zürich

Zurich, Switzerland

Location

Related Publications (1)

  • Eden J, Bruggenwirth IMA, Berlakovich G, Buchholz BM, Botea F, Camagni S, Cescon M, Cillo U, Colli F, Compagnon P, De Carlis LG, De Carlis R, Di Benedetto F, Dingfelder J, Diogo D, Dondossola D, Drefs M, Fronek J, Germinario G, Gringeri E, Gyori G, Kocik M, Kucukerbil EH, Koliogiannis D, Lam HD, Lurje G, Magistri P, Monbaliu D, Moumni ME, Patrono D, Polak WG, Ravaioli M, Rayar M, Romagnoli R, Sorensen G, Uluk D, Schlegel A, Porte RJ, Dutkowski P, de Meijer VE. Long-term outcomes after hypothermic oxygenated machine perfusion and transplantation of 1,202 donor livers in a real-world setting (HOPE-REAL study). J Hepatol. 2025 Jan;82(1):97-106. doi: 10.1016/j.jhep.2024.06.035. Epub 2024 Jul 3.

    PMID: 38969242DERIVED

Study Officials

  • Vincent E de Meijer, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2022

First Posted

August 29, 2022

Study Start

August 24, 2022

Primary Completion

December 31, 2022

Study Completion

August 1, 2023

Last Updated

April 22, 2024

Record last verified: 2024-04

Locations

CH(1)NL(1)