Not Yet RecruitingNot Applicable

Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion

215 participantsStarted 2027-01

Plain-language summary

The purpose of this clinical study is to confirm the safety and effectiveness of dual hypothermic oxygenated perfusion (DHOPE) using the Liver Assist to preserve deceased donor livers for transplantation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participant is able to provide informed consent and HIPAA authorization
. Age ≥18 years
. Participant is registered as an active first-time liver transplant candidate on the United Network for Organ Sharing (UNOS) waiting list for primary liver transplantation
. Participant is willing to comply with the study requirements and procedures

Exclusion criteria

. Participant will undergo concurrent multi-organ transplantations (liver-kidney, liver-lung, etc.)
. Participant is listed for liver transplantation due to fulminant liver failure (UNOS status 1A)
. Participant is listed for a repeat liver transplantation (\>1 graft)
. Participant is pregnant
. Participant is on respiratory (ventilator dependent) and/or cardiocirculatory support (defined as mechanical circulatory support which requires at least one intravenous inotrope to maintain hemodynamics)
. Participant is enrolled in an interventional clinical trial with an investigational drug or device

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Early Allograft Dysfunction

Timeframe: Day 7 (post operative)

Overall graft survival

Timeframe: Day 180 (post operative)

Trial details

NCT IDNCT06916325

SponsorXVIVO Perfusion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10

Contact for this trial

Jaya Tiwari

240-758-3818 jaya.tiwari@xvivogroup.com

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