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Liver TransplantationNCT06804746

DCN for ECD Livers

An observational study of Liver Transplantation, run by Erasmus Medical Center at 2 sites in Netherlands.

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

The goal of this observational study is to learn whether extended criteria donor livers can be safely transplanted after sequential hypo- and normothermic machine perfusion in recipients requiring a liver transplant for end-stage liver disease, including a long-term follow-up. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Transplantation
What is being tested?
DHOPE-COR-NMP
Type of treatment
Surgery or procedure
How many people
143 participants
Where
2 sitesNetherlands
Study dates
1 Mar 2019to 31 Oct 2025
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients (>18 years) undergoing liver transplantation of extended criteria donor livers, which therefore required resuscitation and viability assessment through the previously published DHOPE-COR-NMP protocol based on a blood-based perfusate.

Who may be able to join

  • Adult patients (>18 years old)
  • Donor livers that required resuscitation and viability assessment through the previously published sequential hypo- and normothermic liver machine perfusion (DHOPE-COR-NMP) protocol based on a blood-based perfusate.

Who cannot join

  • Multiorgan transplantation
  • Split liver transplant
  • Living donor liver transplantation
  • Previous donor organ perfusion (e.g. Normothermic Regional Perfusion)

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • University Medical Center Groningen

    Groningen, Provincie Groningen, 9713GZ

  • Erasmus Medical Center

    Rotterdam, South Holland, 3015GD

Other trials in Netherlands

About this study

Official title: Safe Transplantation of Extended Criteria Donor Livers: Two-center Experience With Resuscitation and Viability Assessment of 206 Livers Using Sequential Hypo- and Normothermic Machine Perfusion

The goal of this observational study is to learn whether extended criteria donor livers can be safely transplanted after sequential hypo- and normothermic machine perfusion in recipients requiring a liver transplant for end-stage liver disease, including a long-term follow-up. The main questions it aims to answer are:

  • Death censored graft-survival
  • Overall patient survival
  • Frequency of frequent post-transplant complications (e.g. non-anastomotic biliary strictures)
Read the detailed description

With the increasing shortage of suitable donor livers for transplantation, extended criteria donor (ECD) livers may bridge the gap between available donor organs and donor livers needed. However, these ECD livers are associated with a higher risk of posttransplant complications. With the development of machine perfusion (MP) strategies over the recent years, (dual) hypothermic oxygenated perfusion ((D)HOPE) is established as a safe and effective way to reduce ischemia reperfusion injury. This leads to a decrease in early allograft dysfunction and non-anastomotic biliary strictures (NAS). On the other hand, normothermic machine perfusion (NMP) is mainly used for hepatobiliary functional assessment of liver grafts prior to transplantation. Combining both perfusion techniques through 1 hour of controlled oxygenated rewarming (COR), enables safe selection and transplantation of ECD livers after DHOPE-COR-NMP. Long-term outcomes are now available from two centers.

Being tested
DHOPE-COR-NMP
Keywords
Liver Transplantation, Machine Perfusion, Extended Criteria Donors

What participants receive

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

  • DHOPE-COR-NMPProcedure or surgery

    Resuscitation and viability assessment through the previously published protocol of sequential hypo- and normothermic liver machine perfusion with controlled oxygenated rewarming (DHOPE-COR-NMP) based on a blood-based perfusate.

Study groups in NCT06804746
Study groupRoleWhat they receive
Group 1Adult patients (>18 years) who underwent liver transplantation of donor livers that required resuscitation and viability assessment through the previously published protocol for sequential hypo- and normothermic liver machine perfusion with controlled oxygenated rewarming (DHOPE-COR-NMP) based on a blood-based perfusate.
Receives: Procedure: DHOPE-COR-NMP

What is being measured

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

  1. Death-censored graft survival

    Time from liver transplantation until re-transplantation or death due to graft dysfunction, with censoring of subjects who died with a functioning graft.

    Measured: 1 year post-transplant

Secondary outcomes (12)

  1. Overall patient survival

    Time from liver transplantation until all-cause death

    Measured: 1 year post-transplant

  2. • Overall graft survival

    Time from liver transplantation until re-transplantation or all-cause death.

    Measured: 1 year post-transplant

  3. Number of participants with primary non function

    Livers failing to sustain their primary function, leading to death or re-transplantation within 7 days of the primary procedure, in the presence of patent blood supply and outflow (8).

    Measured: From transplantation until 7 days post-transplant

  4. Occurrence of hepatic arterial thrombosis

    Radiologically or surgically proven thrombosis of the hepatic artery.

    Measured: 1 year post-transplant

  5. Occurrence of portal vein thrombosis

    Radiologically or surgically proven thrombosis of the portal vein.

    Measured: 1 year post-transplant

  6. Occurrence of venous outflow tract obstruction

    Radiologically or surgically proven thrombosis of the main hepatic veins or the inferior vena cava.

    Measured: 1 year post-transplant

  7. Occurrence 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 (5).

    Measured: 1 year post-transplant

  8. Occurrence of anastomotic biliary strictures

    Strictures occurring at the anastomosis of donor choledochal duct and recipient choledochal duct or jejunal Roux-limb.

    Measured: 1 year post-transplant

  9. Occurrence of 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 (9).

    Measured: From 3 days after transplantation until the the first year post-transplant

  10. Biliary complications: as a composite

    A composite of individually studied outcome measures (reported as one single outcome measure), composed of: non-anastomotic biliary strictures, anastomotic biliary strictures and biliary leakage.

    Measured: 1 year post-transplant

  11. Intensive care stay

    Intensive care stay post-transplantation

    Measured: From transplantation until discharge from the Intensive care unit to the ward after transplantation or date of death from any cause during initial admission, whichever came first, assessed up to 6 months

  12. Total hospital stay

    Defined as total hospital stay from transplantation until discharge, including intensive care unit stay

    Measured: From transplantation until discharge after transplantation, or date of death from any cause during initial admission, whichever came first, assessed up to 6 months

Timeline

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

  1. First posted3 Feb 2025
  2. Study start1 Mar 2019
  3. Primary completion1 May 2025
  4. Study completion31 Oct 2025

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
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06804746
Sponsor's protocol ID
MEC-2024-0738
Status last verified
Jan 2026
First submitted
13 Jan 2025
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • de Vries Y, Berendsen TA, Fujiyoshi M, van den Berg AP, Blokzijl H, de Boer MT, van der Heide F, de Kleine RHJ, van Leeuwen OB, Matton APM, Werner MJM, Lisman T, de Meijer VE, Porte R. Transplantation of high-risk donor livers after resuscitation and viability assessment using a combined protocol of oxygenated hypothermic, rewarming and normothermic machine perfusion: study protocol for a prospective, single-arm study (DHOPE-COR-NMP trial). BMJ Open. 2019 Aug 15;9(8):e028596. doi: 10.1136/bmjopen-2018-028596.

    PubMed 31420387

  • van Leeuwen OB, de Vries Y, Fujiyoshi M, Nijsten MWN, Ubbink R, Pelgrim GJ, Werner MJM, Reyntjens KMEM, van den Berg AP, de Boer MT, de Kleine RHJ, Lisman T, de Meijer VE, Porte RJ. Transplantation of High-risk Donor Livers After Ex Situ Resuscitation and Assessment Using Combined Hypo- and Normothermic Machine Perfusion: A Prospective Clinical Trial. Ann Surg. 2019 Nov;270(5):906-914. doi: 10.1097/SLA.0000000000003540.

    PubMed 31633615

  • van Rijn R, Schurink IJ, de Vries Y, van den Berg AP, Cortes Cerisuelo M, Darwish Murad S, Erdmann JI, Gilbo N, de Haas RJ, Heaton N, van Hoek B, Huurman VAL, Jochmans I, van Leeuwen OB, de Meijer VE, Monbaliu D, Polak WG, Slangen JJG, Troisi RI, Vanlander A, de Jonge J, Porte RJ; DHOPE-DCD Trial Investigators. Hypothermic Machine Perfusion in Liver Transplantation - A Randomized Trial. N Engl J Med. 2021 Apr 15;384(15):1391-1401. doi: 10.1056/NEJMoa2031532. Epub 2021 Feb 24.

    PubMed 33626248

  • 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

  • Schlegel A, Porte R, Dutkowski P. Protective mechanisms and current clinical evidence of hypothermic oxygenated machine perfusion (HOPE) in preventing post-transplant cholangiopathy. J Hepatol. 2022 Jun;76(6):1330-1347. doi: 10.1016/j.jhep.2022.01.024.

    PubMed 35589254

  • Foley DP, Fernandez LA, Leverson G, Anderson M, Mezrich J, Sollinger HW, D'Alessandro A. Biliary complications after liver transplantation from donation after cardiac death donors: an analysis of risk factors and long-term outcomes from a single center. Ann Surg. 2011 Apr;253(4):817-25. doi: 10.1097/SLA.0b013e3182104784.

    PubMed 21475025

  • Nemes B, Gaman G, Polak WG, Gelley F, Hara T, Ono S, Baimakhanov Z, Piros L, Eguchi S. Extended-criteria donors in liver transplantation Part II: reviewing the impact of extended-criteria donors on the complications and outcomes of liver transplantation. Expert Rev Gastroenterol Hepatol. 2016 Jul;10(7):841-59. doi: 10.1586/17474124.2016.1149062. Epub 2016 Mar 2.

    PubMed 26831547

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Transplantation, run by Erasmus Medical Center at 2 sites in Netherlands.

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 2 inclusion and 4 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 27 Jan 2026. 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. 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 (time frame: 1 year post-transplant). 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 NCT06804746, which also lists 7 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 27 Jan 2026.

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