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Liver TransplantationHOPExtNCT03929523

Hypothermic Oxygenated Perfusion for Extended Criteria Donors in Liver Transplantation (HOPExt)

A study testing End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE) and classic static cold storage in people with Liver Transplantation, run by Hospices Civils de Lyon at 8 sites in France.

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

Given the scarce donor supply, an increasing number of so-called marginal or extended criteria donor (ECD) organs have been used for liver transplantation. These ECD liver grafts are, however, known to be associated with a higher rate of early allograft dysfunction (EAD) and primary non-function because of a greater… 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?
End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE) and classic static cold storage
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
8 sitesFrance
Study dates
10 Sep 2019to 13 Mar 2023
Phase
Interventional
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

Who may be able to join

  • Provide written informed consent prior to the performance of any study specific procedure
  • Affiliated to the French social security system
  • Recipient age ≥ 18 years
  • Patients undergoing primary liver transplantation.
  • Candidate for a first elective liver transplantation, whatever the indication, with a liver graft harvested from a brain-dead ECD defined by the presence of at least one of the following criteria:
  • Donor age > 65 years
Show all 12Show fewer
  • Intensive care unit stay > 7 days
  • BMI > 30
  • Proven macro-steatosis biopsy ≥ 30%
  • Natremia > 155 mmol/L at any time
  • AST > 150 IU/mL at any time
  • ALT > 170 IU/mL at any time.

Who cannot join

  • Fulminant hepatic failure
  • Retransplantation
  • Split liver transplantation
  • Living donor liver transplantation
  • Grafts donated after cardiac arrest (DCD grafts)
  • Domino transplantation
Show all 14Show fewer
  • Combined liver transplant
  • Unexpected medical contraindication to liver transplantation
  • Patient participating in other interventional research, excluding routine care research (old regulation) and category 2 research not interfering with primary endpoint analysis
  • Patient under legal protection
  • Patient deprived of liberty by a judicial or administrative decision
  • Patient refusing to participate in the study
  • Pregnant or lactating women
  • Inability to understand information concerning the protocol

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • Department of HPB surgery and liver transplantation Beaujon University Hospital

    Clichy, 92210

  • CHU Grenoble Alpes - Department of HPB surgery and liver transplantation

    Grenoble, 38000

  • Department of HPB surgery and liver transplantation Claude Huriez University Hospital

    Lille, 59037

  • Hospices Civils de Lyon

    Lyon, 69004

  • APHP - Pitié Salpétrière

    Paris, 75013

  • Department of HPB surgery and liver transplantation Pontchaillou University Hospital

    Rennes, 35033

  • Hôpital Hautepierre - Department of HPB surgery and liver transplantation

    Strasbourg, 67200

  • Department of HPB surgery and liver transplantation Paul Brousse University Hospital

    Villejuif, 94804

Other trials in France

About this study

Official title: End-ischemic Hypothermic Oxygenated Perfusion for Extended Criteria Donors in Liver Transplantation - A Multicenter, Randomized Controlled Trial

Given the scarce donor supply, an increasing number of so-called marginal or extended criteria donor (ECD) organs have been used for liver transplantation. These ECD liver grafts are, however, known to be associated with a higher rate of early allograft dysfunction (EAD) and primary non-function because of a greater vulnerability to ischemia-reperfusion injury. The end-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE) technique may improve outcomes of liver transplantation with ECD grafts by decreasing reperfusion injury.

The study aim is to assess the efficacy of HOPE used before transplantation of ECD liver grafts from brain-dead donors in reducing postoperative EAD within the first 7 postoperative days (POD) compared to simple cold static storage.

The study is comparative open-label, multicenter, national, prospective, randomized, in two parallel groups, using the gold standard procedure as control.

Read the detailed description

This multicentric randomized controlled trial concerns adult patients undergoing whole liver transplantation in any of the 8 participating centers in France, who will receive an ECD liver graft from a brain-dead donor.

After providing written informed consent prior to the performance of any study specific procedure, the recruited patients will be randomized either in the experimental group (HOPE group) or in the control group.

In the HOPE group, ECD liver grafts will undergo a hypothermic oxygenated perfusion (HOPE) via the portal vein for a period of 1 to 4 hours (minimum 1 hour) after the "back-table" phase (graft preparation), in parallel with the recipient hepatectomy, using the CE-certified Liver Assist® perfusion pump/device (Organ Assist®, the Netherlands) with Machine Perfusion Solution (Belzer-MPS, CE-certified).

The control group will consist of a classic static cold (4°C) storage with Institute George Lopez (IGL-1)® solution from graft harvesting until liver transplantation, which is the gold standard procedure in liver transplantation.

The primary endpoint will be early allograft dysfunction (EAD) according to Olthoff's criteria, which will be compared with the Model of Early Allograft Function score (MEAF score) and the Liver Graft Assessment Following Transplantation risk factor (L-GrAFT).

According to the primary endpoint, a sample size of 133 patients per randomized group (266 in total) is needed. The duration of the inclusion period is expected to be 36 months with a 1-year follow-up for each patient.

The potential impacts of the study are expected on 3 levels: (1) for the patient, decreased postoperative morbidity and mortality of liver transplantation with ECD donors; (2) for the French liver transplantation community, familiarization with liver machine perfusion, and (3) economically, decreased costs of liver transplantation (health economic analysis included in the study).

Being tested
End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE), classic static cold storage
Keywords
Liver Transplantation, Liver machine perfusion, extended criteria donor

What participants receive

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

  • End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE)Device

    In the experimental group, ECD liver grafts will first undergo a classical static cold (4°C) storage with Institute George Lopez (IGL-1)® solution from graft harvesting until transport to the transplantation center. They will then undergo a hypothermic oxygenated perfusion (HOPE) via the portal vein for a period of 1 to 4 hours (minimum 1 hour) after the "back-table" phase (graft preparation), in parallel with the recipient hepatectomy, using the CE-certified Liver Assist® perfusion pump/device (Organ Assist®, the Netherlands) with Machine Perfusion Solution (Belzer-MPS, CE-certified).

  • classic static cold storageDevice

    The control group will consist of a classic static cold (4°C) storage with Institute George Lopez (IGL-1)® solution from graft harvesting until liver transplantation, which is the gold standard procedure in liver transplantation

Study groups in NCT03929523
Study groupRoleWhat they receive
HOPE groupExperimentalhypothermic oxygenated perfusion
Receives: Device: End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE)
Control groupActive comparatorclassic static cold storage
Receives: Device: classic static cold storage

What is being measured

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

  1. Early allograft dysfunction (EAD) according to Olthoff criteria.

    EAD is defined by the presence of at least one of the following criteria:

    • Bilirubin level > 10 mg/dL (i.e. 171 µmol/L) on POD 7
    • International Normalized Ratio (INR) > 1.6 on POD 7
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels > 2000 IU/L within the first 7 PODs Additionally EAD will be also assessed by the MEAF score and the L-GrAFT risk factor.

    Measured: During the first postoperative week

Secondary outcomes (10)

  1. Model of Early Allograft Function score (MEAF score).

    The MEAF score includes bilirubin, ALT max and INR max at postperative day 3. Range 0 (better outcome) to 10 (worse outcome)

    Measured: During the first 3 postoperative days.

  2. Liver Graft Assessment Following Transplantation risk factor (L-GrAFT)

    L-GrAFT includes aspartate aminotransferase (AST), INR, total bilirubin and platelets every day until postoperative day 10. Range -6 (better outcome) to +6 (worse outcome)

    Measured: During the first 10 postoperative days.

  3. Untargeted liver graft metabolic profiling

    Untargeted liver graft metabolic profiling (by High-Resolution Nuclear Magnetic Resonance - 1H HR-Nuclear Magnetic Resonance (NMR) Spectrometer) on liver graft biopsies on the back-table before and after liver machine perfusion.

    Measured: Day of liver transplantation (Day 0)

  4. Occurrence of post-reperfusion syndrome

    Defined as a 50% decrease in median arterial pressure during the 5 minutes following the graft revascularization

    Measured: Day of liver transplantation (Day 0)

  5. 90-day morbidity and mortality

    Severe postoperative complications (Dindo-Clavien ≥3) / death

    Measured: During the first 90 days after surgery.

  6. Length of intermediate care unit stay (days)

    Duration of intermediate care unit stay

    Measured: From randomization until intermediate care unit discharge, estimated up to 7 days

  7. Length of hospital stay (days)

    Duration of hospital stay

    Measured: From randomization until hospital discharge, estimated up to 21 days

  8. Liver contrast-enhanced MRI including a Magnetic Resonance CholangioPancreatography (MRCP)

    Assessment of intra- and extrahepatic biliary complications (except for patients who underwent a re-transplanted during the study).

    Measured: Within 1 year after liver transplantation

  9. 3-month and one-year patient and graft survivals

    Actuarial graft and patient's survival rates

    Measured: within one year after liver transplantation

  10. Hospital costs (Euros) of liver transplantation

    Hospital costs of liver transplantation

    Measured: At one year after liver transplantation

Timeline

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

  1. First posted29 Apr 2019
  2. Study start10 Sep 2019
  3. Primary completion13 Mar 2023
  4. Study completion13 Mar 2023

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03929523
Sponsor's protocol ID
69HCL19_0034
Other IDs
2019-A00546-51
Acronym
HOPExt
Status last verified
Nov 2025
First submitted
9 Apr 2019
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pradat P, Pantel S, Maynard M, Lalande L, Thevenon S, Adam R, Allard MA, Robin F, Rayar M, Boleslawski E, Scatton O, Chirica M, Faitot F, Bachellier P, Soubrane O, Mohkam K, Mabrut JY, Lesurtel M. End-ischemic hypothermic oxygenated perfusion for extended criteria donors in liver transplantation: a multicenter, randomized controlled trial-HOPExt. Trials. 2023 Jun 6;24(1):379. doi: 10.1186/s13063-023-07402-0.

    PubMed 37280696

  • Lesurtel M, Mohkam K, Allard MA, Adam R, Robin F, Rayar M, Boudjema K, Chebaro A, Boleslawski E, Savier E, Scatton O, Girard E, Chirica M, Dokmak S, Soubrane O, Faitot F, Bachellier P, Hervieu V, Guerre P, Atfeh J, Pantel S, Thevenon S, Maynard M, Pradat P, Mabrut JY. A French multicenter randomized controlled trial of hypothermic oxygenated perfusion in extended criteria donor liver transplantation. Am J Transplant. 2026 Mar;26(3):607-620. doi: 10.1016/j.ajt.2025.10.006. Epub 2025 Oct 17.

    PubMed 41110608

Questions about this trial

What is this clinical trial studying?

A study testing End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE) and classic static cold storage in people with Liver Transplantation, run by Hospices Civils de Lyon at 8 sites in France.

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 12 inclusion and 14 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. 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?

Early allograft dysfunction (EAD) according to Olthoff criteria. (time frame: During the first postoperative week). 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 NCT03929523, which also lists 2 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 21 Nov 2025.

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