A machine that keeps donor livers alive outside the body — could it transform transplantation?
NCT ID NCT05045794
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Cleveland Clinic
Weston, Florida, 33331, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Henry Ford Hospital
Detroit, Michigan, 48202, United States
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Houston Methodist Hospital
Houston, Texas, 77030, United States
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Indiana University
Indianapolis, Indiana, 46202, United States
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Lahey Hospital and Medical Center
Burlington, Massachusetts, 01895, United States
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Loma Linda University Medical Center
San Bernadino, California, 92408, United States
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Mayo Clinic
Jacksonville, Florida, 32224, United States
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Mount Sinai Hospital
New York, New York, 10029, United States
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Nebraska Medical Center
Omaha, Nebraska, 68198, United States
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Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
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Stanford University Medical Center
Stanford, California, 94305, United States
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University of California San Francisco
San Francisco, California, 94143, United States
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University of Wisconsin Madison
Madison, Wisconsin, 53792, United States
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Washington University St. Louis
St Louis, Missouri, 63110, United States
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