Rejected livers get a second chance on a pump
NCT ID NCT04483102
First seen Sep 23, 2026 ยท Last updated Sep 23, 2026
Summary
This trial tests whether donor livers that other centers have rejected can be made usable by keeping them warm and pumping them with oxygen and nutrients outside the body, a method called normothermic machine perfusion. Researchers will transplant livers that meet viability criteria into consenting patients and track how many grafts and patients survive at six months. They will compare outcomes with patients who receive standard cold-stored livers, using local and national registry data.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Normothermic machine perfusion of discarded donor livers using the OrganOx metra device
- What this could lead to
- If it works, more donor livers could become usable, which may shorten waiting times for people who need a liver transplant.
- What could go wrong
- The trial is small and single-center, so results may not apply everywhere. Perfused livers could still fail after transplant, and recipients face standard transplant risks such as rejection and infection.
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
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24 people
The number who actually took part.
- Started
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Dec 2020
- Finished
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May 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
PRE-NMP DECLINED LIVER ELIGIBILITY: Inclusion Criteria: * DCD donor aged 6 years or greater and liver weight between 1 kg and 3.4 kg, with functional warm ischemic time (defined as the period between the systolic blood pressure less than 60 mmHg to the time of commencing donor aortic perfusion) in DCD donors less than 40 minutes * DCD asystolic warm ischemia time (from heartbeat stopping to initiation of cold flush) less than 15 minutes * DBD donor aged 6 years or greater and liver weight between 1 kg and 3.4 kg, with less than 8 hours cold ischemia time and DCD livers with less than 7 hours cold ischemia time (defined as the interim from initiation of donor in vivo cold organ preservation to removal of the liver graft from cold storage) * 'Rapid Recovery' donors for liver procurement, meeting the above criteria * Suboptimal in situ flush Exclusion Criteria: * DBD or DCD donor less than 6 years old * DCD grafts with donor functional warm ischemic time (defined as the period between the systolic blood pressure less than 60 mmHg to the time of commencing donor aortic perfusion) greater than or equal to 40 minutes * DCD asystolic warm ischemia time (from heartbeat stopping to initiation of cold flush) greater than or equal to 15 minutes * DBD livers with cold ischemia time greater than or equal to 8 hours and DCD livers with greater than or equal to 7 hours cold ischemia time * Donor serum bilirubin greater than or equal to 5 mg/dL * Liver weight less than 1 kg or greater than or equal to 3.5 kg * Grafts from patients with HIV infection * Cirrhotic livers * Livers with bridging fibrosis LIVER TRANSPLANTATION - HUMAN Inclusion criteria: * Subject must be greater than or equal to 18 years of age. * Subject with end-stage liver disease who is actively listed for primary liver transplantation on the UNOS waiting list * Subject, or a legally authorized representative, has given informed consent to participate in the study * Subject has a frailty classification of "Mild frailty/No frailty (Robust)", based on the Liver Frailty Index (LFI), which has been assessed within 6 months prior to liver transplant OR Subject is able to perform \>350 m on a 6 minute walk test (6MWT) within 6 months prior to liver transplant. * In all cases, the "most recent" (and within 6 months prior to transplant) measurement of LFI or 6MWT will be used to determine eligibility. Exclusion criteria: * Subject is currently listed as a UNOS status 1A. * Subject is requiring oxygen therapy via ventilator/respiratory support. * Subject is planned to undergo simultaneous solid organ transplant. * Subject is pregnant at the time of transplant. * Subject MELD score 29 or higher * Subject receives re-transplantation of liver.
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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
Locations
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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