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Machine perfusion may keep livers healthier for transplant

NCT ID NCT07595627

Disease control Sponsor: University of Sao Paulo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two methods of preserving livers from deceased donors before transplant: a machine that pumps oxygenated cold fluid through the liver (hypothermic machine perfusion) versus the standard ice-cooled storage. Forty adult liver transplant patients will be randomly assigned to receive a liver preserved by one of these methods. Researchers will track early liver function, complications, and recovery over one year to see if the machine method reduces injury and improves outcomes.

What this could mean

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

Active substance
Hypothermic machine perfusion device
What this could lead to
If successful, this could improve liver transplant outcomes by reducing early graft injury and complications.
What could go wrong
This is a small, early-stage study with only 40 participants. The device may not show significant benefit over standard cold storage, and results may not apply to all transplant settings.

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 40 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 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.

Donor-related inclusion criteria: * Liver donors with confirmed diagnosis of brain death. * Extended criteria donors (ECD). * Age ≥18 years. * Family consent for organ donation obtained. * Negative serology for HTLV, HIV, Chagas disease, and hepatitis B and C. Recipient-related inclusion criteria: * Adult patients (≥18 years) undergoing liver transplantation. * Diagnosis of end-stage liver disease or indication for liver transplantation. * Candidates for primary liver transplantation. * Ability to understand and provide written informed consen Donor-related exclusion criteria: * Presence of moderate or severe hepatic steatosis. * Pediatric donors. * Donors classified as ideal, defined by the simultaneous presence of all of the following criteria: Age \<35 years, Body mass index (BMI) \<28 kg/m², No history of cardiopulmonary resuscitation, Norepinephrine requirement \<0.5 µg/kg/min, Liver enzymes (AST or ALT) ≥2 times the upper limit of normal, Intensive care unit stay ≤7 days Recipient-related exclusion criteria: * Complex portal vein thrombosis (grade III or IV). * Combined or dual organ transplantation. * Retransplantation. * Acute liver failure. * MELD score \>30. * History of multiple prior liver or biliary surgeries.

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Conditions

The condition(s) this trial relates to.

chronic liver failure ischemia reperfusion injury liver failure

As listed by the trial registrant

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

Liver failure Liver transplant

How to take part

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  1. The places running it

    1 site. 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

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Contacts and locations

Locations

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP)

    São Paulo, São Paulo, 05403-000, Brazil

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