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

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.

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Key information

Conditions

Liver Transplant Surgery Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Participant 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

For participants with hepatocellular carcinoma (HCC) as indication for Orthotopic Liver Transplantation, the tumor must be within Milan Criteria or down-staged to Milan Criteria at the time of transplant
Participant is willing to comply with the study requirements and procedures

Participant 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
Presence of other medical, social, or psychological conditions that in the investigator's opinion, could limit the participant's ability to participate in the clinical trial

Treatment and study plan

dual hypothermic oxygenated perfusion (DHOPE)

Device

Clinically, end-ischemic DHOPE has been shown to restore hepatic ATP, reduce reperfusion injury, and improve outcomes after deceased donor liver transplantation. Recent prospective and retrospective clinical studies detail the safety and feasibility of prolonged preservation of donor livers with DHOPE for up to 20 hours; prolonged perfusion has shown similarly low rates of serious adverse events, a potential protective effect in mitigating acute kidney injury and may facilitate decreased frequency of discarded and nonuse of donor livers.

Primary outcomes

Incidence of Early Allograft Dysfunction

Time frame: Day 7 (post operative)
Incidence of Early Allograft Dysfunction (EAD) defined according to the Olthoff criteria as the presence of one or more of the following postoperative laboratory analyses observations reflective of liver injury and function:
- Bilirubin ≥ 10mg/dL on postoperative day (POD) 7, or
- International normalized ratio (INR) ≥ 1.6 on POD 7, or
- Alanine or aspartate aminotransferases (AST and ALT) > 2000 IU/L within the first 7 PODs
Overall graft survival

Time frame: Day 180 (post operative)

Overall graft survival

Study contacts

Contact information is provided by the study sponsor or research team.

Jaya Tiwari

CONTACT

[email protected]

240-758-3818

Sponsors and collaborators

Lead sponsor

XVIVO Perfusion

Industry

Registry information

Official study title

DeLIVER Trial: A Prospective, Multi-Center, Single-Arm, Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion

Important dates

Study start: 2027
Primary completion: 2028
Study completion: 2033
First posted: Apr 8, 2025
Registry last updated: Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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