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Warm liver transplants: could ditching the ice bath reduce organ damage?

NCT ID NCT07692490

Disease control Sponsor: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This study tests a new approach for liver transplantation: after keeping the donor liver warm on a machine, doctors skip the usual cold flush before implanting it. Instead, they use a room-temperature albumin rinse. The goal is to see if avoiding sudden temperature changes reduces early liver injury (called early allograft dysfunction). The trial includes 170 adult liver transplant recipients across multiple centers and follows them for 90 days after surgery.

What this could mean

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

Active substance
No recooling procedure (room-temperature albumin flush)
What this could lead to
If successful, this simpler approach could reduce early liver damage after transplant, potentially improving patient recovery and graft survival.
What could go wrong
This is a relatively small, early-stage trial (170 participants) testing a procedural change. The benefit may be modest or not appear, and there is a risk of unforeseen complications from omitting the standard cold preservation step.

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

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

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: * Age ≥18 years. * Listed for primary liver transplantation at the participating institution. * Assigned a liver graft preserved with normothermic machine perfusion or sequential hypothermic- normothermic machine perfusion (SHNMP). * Signed and dated informed consent prior study inclusion. Exclusion Criteria: * Pediatric patients (age \< 18 years) * Patients undergoing re-transplantation (history of previous liver transplantation) * Patients with acute liver failure * Patients undergoing multi-organ transplantation (e.g., liver-kidney, liver-heart) * Temporarily unconscious patients * Patients unable to freely express consent.

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Conditions

The condition(s) this trial relates to.

chronic liver failure ischemia reperfusion injury

As listed by the trial registrant

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

Early allograft dysfunction Ischemia reperfusion injury Liver transplantation (LT)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Papa Giovanni XXIII

    NOT_YET_RECRUITING

    Bergamo, 24127, Italy

  • Azienda Ospedale-Università di Padova

    NOT_YET_RECRUITING

    Padova, 35128, Italy

  • Azienda Ospedaliera San Camillo Forlanini

    NOT_YET_RECRUITING

    Roma, 00152, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona

    NOT_YET_RECRUITING

    Verona, 37126, Italy

  • Azienda Ospedaliero Universitaria Pisana

    NOT_YET_RECRUITING

    Pisa, 56126, Italy

  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari - Ospedale Giovanni XXIII

    NOT_YET_RECRUITING

    Bari, 70124, Italy

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I - Sapienza Università di Roma

    NOT_YET_RECRUITING

    Roma, 00161, Italy

  • Fondazione PTV - Policlinico Tor Vergata

    NOT_YET_RECRUITING

    Roma, 00133, Italy

  • Fondazione Policlinico "Agostino Gemelli" IRCCS

    NOT_YET_RECRUITING

    Roma, 00168, Italy

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    NOT_YET_RECRUITING

    Bologna, 40138, Italy

  • IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione

    RECRUITING

    Palermo, 90127, Italy

  • Ospedale Università Policlinico San Martino - IRCCS

    NOT_YET_RECRUITING

    Genova, 16132, Italy

  • Università Politecnica delle Marche, AUO delle Marche

    NOT_YET_RECRUITING

    Ancona, 60126, Italy

  • Università di Modena e Reggio Emilia

    NOT_YET_RECRUITING

    Modena, 41124, Italy

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