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A machine that keeps donor livers alive outside the body — could it transform transplantation?

NCT ID NCT05045794

Disease control Sponsor: Bridge to Life Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial tests whether a device called VitaSmart, which pumps cold, oxygenated preservation fluid through a donor liver before transplant, can reduce early organ dysfunction and improve survival compared with the usual method of simply storing the liver on ice. About 228 adults with end-stage liver disease awaiting a transplant will be randomly assigned to receive a liver preserved either by standard cold storage alone or by cold storage followed by VitaSmart machine perfusion. The study tracks early graft function, graft survival, and patient survival up to 12 months.

What this could mean

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

Active substance
VitaSmart Liver Machine Perfusion System — a device that pumps cold, oxygenated preservation fluid through a donor liver before transplantation
What this could lead to
If it works, this could reduce early liver damage after transplant and improve graft survival, potentially expanding the pool of usable donor livers.
What could go wrong
This is a pivotal trial, but machine perfusion adds complexity and cost; it may not meaningfully improve outcomes over standard cold storage, and device-related complications are possible.

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

228 people

The number who actually took part.

Started

Dec 2021

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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.

Donation after Brain Death (DBD) Liver Inclusion Criteria (one or more): * Donor age 50-85 years * Anticipated cold ischemia time 10-15 hours (excluding HOPE duration) * Macrosteatosis 10-40% * Terminal ALT 250-1500 IU/ml * Peak ALT within 3 days 1000-3000 IU/ml * Terminal total bilirubin 2-4 mg/dl Donation after Brain Death (DBD) Liver Exclusion Criteria (one or more): * Donor age \<18 or \>85 years * Anticipated cold ischemia \>15 hours * Macrosteatosis \>40% * Terminal ALT \>1500 IU/ml * Peak ALT within 3 days \>3000 IU/ml * Terminal total bilirubin \>4 mg/dl * Presence of hemodynamic and/or anatomical donor abnormalities that, in the opinion of the Investigator, make the liver allograft unsuitable for transplant into the recipient subject * Liver intended for split transplant * Liver from living donor * Donor terminal serum Na \>160 mmol/L Donation after Cardio-circulatory Death (DCD) Liver Inclusion Criteria (all): * Donor age 18-60 years * Anticipated cold ischemia time \<12 hours (excluding HOPE duration) * Functional warm ischemia time ≤35 minutes, defined as interval from the time of onset of donor hypotension (MAP \<50mmHg) until the time of donor cross clamp * Macrosteatosis ≤20% * Terminal ALT ≤500 IU/ml * Peak ALT within 3 days ≤2000 IU/ml * Terminal total bilirubin ≤3 mg/dl Donation after Cardio-circulatory Death (DCD) Liver Exclusion Criteria (one or more): * Presence of hemodynamic and/or anatomical donor abnormalities that, in the opinion of the Investigator, make the liver allograft unsuitable for transplant into the recipient subject * Liver intended for split transplant * Liver from living donor * Donor terminal serum Na \>160 mmol/L Recipient Inclusion Criteria (one or more): * Subject (or legally authorized representative) is able to provide informed consent and HIPAA authorization * Subject is male or female and at least 18 years of age * Subject is registered as an active liver recipient on the UNOS waiting list for liver transplantation * Subject will undergo primary liver transplantation * Subject is willing to comply with the study requirements and procedures * Subject with hepatocellular carcinoma as indication for Orthotopic Liver Transplantation; the tumor must be within Milan Criteria or down-staged to Milan Criteria Recipient Exclusion Criteria (one or more): * Subject will undergo multiple organ transplantations (liver-kidney, liver-lung, etc.) * Subject is listed for liver transplantation due to fulminant liver failure (UNOS status 1A) * Subject is pregnant * Subject is on respiratory (ventilator dependent) and/or cardiocirculatory support (requires at least one intravenous inotrope to maintain hemodynamics) * Subject is enrolled in an interventional clinical trial with an investigational drug or device

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Conditions

The condition(s) this trial relates to.

chronic liver failure End Stage Liver Disease hepatocellular carcinoma liver failure

As listed by the trial registrant

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

End stage liver disease Liver failure

Contacts and locations

Locations

  • Cleveland Clinic

    Weston, Florida, 33331, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01895, United States

  • Loma Linda University Medical Center

    San Bernadino, California, 92408, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Wisconsin Madison

    Madison, Wisconsin, 53792, United States

  • Washington University St. Louis

    St Louis, Missouri, 63110, United States

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