DCN for ECD Livers

NCT06804746 | Completed

• 1 other identifier: MEC-2024-0738
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 2

Brief 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. 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)

Conditions

Liver Transplantation

Keywords

Liver Transplantation; Machine Perfusion; Extended Criteria Donors

Outcome Measures

Primary Outcomes (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.

  1 year post-transplant

Secondary Outcomes (12)

• Overall patient survival

  1 year post-transplant

• • Overall graft survival

  1 year post-transplant

• Number of participants with primary non function

  From transplantation until 7 days post-transplant

• Occurrence of hepatic arterial thrombosis

  1 year post-transplant

• Occurrence of portal vein thrombosis

  1 year post-transplant

Other Outcomes (1)

• Composite of post-transplant incidence of biliary interventions

  Until 6 months after liver transplantation

Study Arms (1)

Group 1

Adult 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.

Procedure: DHOPE-COR-NMP

Interventions

DHOPE-COR-NMP PROCEDURE

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.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: collaborator
• Erasmus Medical Center: lead

Study Sites (2)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location

Related Publications (7)

• 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.

  PMID: 31420387 BACKGROUND

• 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.

  PMID: 31633615 BACKGROUND

• 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.

  PMID: 33626248 BACKGROUND

• 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: 38969242 BACKGROUND

• 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.

  PMID: 35589254 BACKGROUND

• 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.

  PMID: 21475025 BACKGROUND

• 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.

  PMID: 26831547 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of HPB- and Transplant Surgery

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 3, 2025
• Study Start: March 1, 2019
• Primary Completion: May 1, 2025
• Study Completion: October 31, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

NL (2)