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Organ PreservationHOPE-REALNCT05520320

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

An observational study of Organ Preservation and Liver Transplantation, run by University Medical Center Groningen at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Hypothermic oxygenated machine perfusion (any device)
Type of treatment
Medical device
How many people
1,202 participants
Where
2 sitesin 2 countries
Study dates
24 Aug 2022to 1 Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Netherlands1 site

  • University Medical Center Groningen

    Groningen

Other trials in Netherlands

Switzerland1 site

  • University Hospital Zürich

    Zurich

Other trials in Switzerland

About this study

Official title: 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)

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).

Being tested
Hypothermic oxygenated machine perfusion (any device)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 5-years

Secondary outcomes (11)

  1. Overall graft survival

    Defined as time from liver transplantation until re-transplantation or all-cause death

    Measured: Up to 5-years

  2. Overall patient survival

    Defined as time from liver transplantation until all-cause death

    Measured: Up to 5-years

  3. Arterial and biliary complication-free survival (ABCFS)

    Defined as time from liver transplantation until occurrence of an arterial or biliary complication of Dindo-Clavien grade ≥3, dated at the time of interventional, endoscopic, or surgical treatment required to correct it (Savier E, De Rycke Y, Lim C, et al. Novel Composite Endpoint for Assessing Outcomes in Liver Transplantation: Arterial and Biliary Complication-Free Survival. Liver Transpl. 2022;28(1):75-87. doi:10.1002/lt.26269)

    Measured: Up to 5-years

  4. Incidence of biliary complications

    Defined as a composite of:

    • Non-anastomotic biliary strictures: any irregularity or narrowing of the lumen of the intrahepatic or extrahepatic donor bile ducts, excluding the biliary anastomosis, diagnosed with the use of cholangiography in combination with clinical symptoms (e.g., jaundice or cholangitis) or an elevation of cholestatic laboratory variables, in the presence of a patent hepatic artery
    • Anastomotic biliary strictures: strictures occurring at the anastomosis of donor choledochal duct and recipient choledochal duct or jejunal Roux-limb
    • Biliary leakage: fluid with an elevated (>3x serum) bilirubin level in the abdominal drain or intra-abdominal fluid on or after post-operative day 3 or the need for radiological intervention (i.e. interventional drainage) owing to biliary collections or re-laparotomy due to biliary peritonitis

    Measured: Up to 5-years

  5. Incidence of vascular complications

    Defined as a composite of:

    • Hepatic arterial thrombosis: radiologically or surgically proven thrombosis of the hepatic artery
    • Portal vein thrombosis: radiologically or surgically proven thrombosis of the portal vein
    • Venous outflow tract obstruction: radiologically or surgically proven thrombosis of the main hepatic veins or the inferior vena cava

    Measured: Up to 5-years

  6. Incidence of acute cellular rejection

    Defined as biopsy proven Banff grade 2 or 3 rejection (Demetris AJ, Bellamy C, Hübscher SG, et al. 2016 Comprehensive Update of the Banff Working Group on Liver Allograft Pathology: Introduction of Antibody-Mediated Rejection. Am J Transplant. 2016;16(10):2816-2835. doi:10.1111/ajt.13909)

    Measured: Up to 5-years

  7. Incidence of chronic rejection

    Defined as histopathological evidence of immunologic injury with irreversible damage to the bile ducts, arteries, and veins (Demetris A, Adams D, Bellamy C, et al. Update of the International Banff Schema for Liver Allograft Rejection: working recommendations for the histopathologic staging and reporting of chronic rejection. An International Panel. Hepatology. 2000;31(3):792-799. doi:10.1002/hep.510310337)

    Measured: Up to 5-years

  8. Incidence of re-transplantation

    Defined as proportion of patients who underwent liver re-transplantation for any cause

    Measured: Up to 5-years

  9. Incidence of recurrence of primary disease (including recurrence of malignancies)

    Defined as histological or radiologically confirmed recurrence

    Measured: Up to 5-years

  10. Incidence of new-onset chronic kidney disease

    Defined as renal impairment (kidney morphology, pathology, imaging, blood or urine composition abnormalities) persisting for >3 months with or without eGFR decrease, and/or eGFR <60 for >3 months with or without renal impairment (Levey AS, Eckardt K-U, Tsukamoto Y, et al. Definition and Classification of Chronic Kidney Disease: A Position Statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100. doi: 10.1111/j.1523-1755.2005.00365.x)

    Measured: Up to 5-years

  11. Incidence of new-onset diabetes after transplantation

    Defined as symptoms of diabetes plus casual plasma glucose levels ≥200 mg/dL (11.1 mmol/L) or fasting plasma glucose ≥126 mg/dL (7.0 mmol/L) or 2 hours plasma glucose ≥200 mg/dL (11.1 mmol/L during an oral glucose tolerance testing (Davidson J, Wilkinson A, Dantal J, et al. New-onset diabetes after transplantation: 2003 International consensus guidelines. Proceedings of an international expert panel meeting. Barcelona, Spain, 19 February 2003. Transplantation. 2003;75(10 Suppl):SS3-24. doi:10.1097/01.TP.0000069952.49242.3E)

    Measured: Up to 5-years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2022
  2. Study start24 Aug 2022
  3. Primary completion31 Dec 2022
  4. Study completion1 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05520320
Sponsor's protocol ID
HOPE-REAL study
Acronym
HOPE-REAL
Status last verified
Apr 2024
First submitted
25 Aug 2022
Last updated
22 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Eden J, Muller PC, Kuemmerli C, Bongini M, Albanesi F, Sposito C, 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, Guidetti C, Gyori G, Kocik M, Kucukerbil EH, Koliogiannis D, Lam HD, Lurje G, Magistri P, Monbaliu D, Moumni ME, Muller BP, Patrono D, Polak WG, Porte RJ, Ravaioli M, Rayar M, Romagnoli R, Sorensen G, Uluk D, Clavien PA, Mazzaferro V, Dutkowski P, de Meijer VE. HCC recurrence in liver transplants treated with hypothermic oxygenated machine perfusion: An international matched cohort study. JHEP Rep. 2026 Jan 21;8(3):101732. doi: 10.1016/j.jhepr.2026.101732. eCollection 2026 Mar.

    PubMed 41737541

  • Eden J, Muller PC, Kuemmerli C, Aegerter N, Bruggenwirth IMA, Berlakovich G, Buchholz BM, Botea F, Camagni S, Cescon M, Cillo U, Colli F, De Carlis LG, De Carlis R, Di Benedetto F, Dingfelder J, Diogo D, Dondossola D, Drefs M, Fronek J, Germinario G, Gringeri E, Guidetti C, Gyori G, Kocik M, Kucukerbil EH, Koliogiannis D, Lurje G, Magistri P, Monbaliu D, El Moumni M, Muller B, Patrono D, Polak WG, Porte RJ, Ravaioli M, Rayar M, Romagnoli R, Sorensen G, Uluk D, Clavien PA, de Meijer VE, Dutkowski P. Life Expectancy of Transplanted Livers: HOPE Against Aging? Ann Surg. 2025 Nov 1;282(5):765-771. doi: 10.1097/SLA.0000000000006883. Epub 2025 Aug 7.

    PubMed 40772946

  • 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.

    PubMed 38969242

Questions about this trial

What is this clinical trial studying?

An observational study of Organ Preservation and Liver Transplantation, run by University Medical Center Groningen at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death-censored graft survival, assessed by survival analysis methods (time frame: Up to 5-years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05520320, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.

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