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Rejected livers get a second chance on a pump

NCT ID NCT04483102

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 23, 2026 · 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

24 people

The number who actually took part.

Started

Dec 2020

Finished

May 2025

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.

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

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.