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New machine may help 'Marginal' donor livers work better after transplant

NCT ID NCT03929523

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device that pumps cold, oxygenated fluid through donor livers before transplant. The goal was to see if it reduces early organ damage in livers from older or higher-risk donors. 266 liver transplant patients took part. The approach could help more people get successful transplants by improving the quality of donated organs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hypothermic Oxygenated Machine Perfusion (HOPE) device
What this could lead to
If it works, this could reduce early liver damage after transplant, helping more patients get successful transplants from older or higher-risk donors.
What could go wrong
This is a completed trial, but results may not apply to all transplant centers or donor types. The device adds time and complexity to the transplant process.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

266 people

The number who actually took part.

Started

Sep 2019

Finished

Mar 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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. Exclusion Criteria: * Fulminant hepatic failure * Retransplantation * Split liver transplantation * Living donor liver transplantation * Grafts donated after cardiac arrest (DCD grafts) * Domino transplantation * 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

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Conditions

The condition(s) this trial relates to.

chronic liver failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Liver transplantation

Contacts and locations

Locations

  • APHP - Pitié Salpétrière

    Paris, 75013, France

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

    Grenoble, 38000, France

  • Department of HPB surgery and liver transplantation Beaujon University Hospital

    Clichy, 92210, France

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

    Lille, 59037, France

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

    Villejuif, 94804, France

  • Department of HPB surgery and liver transplantation Pontchaillou University Hospital

    Rennes, 35033, France

  • Hospices Civils de Lyon

    Lyon, 69004, France

  • Hôpital Hautepierre - Department of HPB surgery and liver transplantation

    Strasbourg, 67200, France

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