Liver Transplant SurgeryNCT06916325
Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion
A study testing dual hypothermic oxygenated perfusion (DHOPE) in people with Liver Transplant Surgery and Liver Transplantation, run by XVIVO Perfusion.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Surgery, Liver Transplantation
- What is being tested?
- dual hypothermic oxygenated perfusion (DHOPE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Apr 2033
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: DeLIVER Trial: A Prospective, Multi-Center, Single-Arm, 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.
- Conditions
- Liver Transplant Surgery, Liver Transplantation
- Being tested
- dual hypothermic oxygenated perfusion (DHOPE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants requiring liver transplant | Experimental | Extended criteria donor donation after brain death (ECD-DBD) or donation after circulatory death (DCD) donor organs will be recovered, transported via static cold storage (SCS), and undergo dual hypothermic oxygenated perfusion (DHOPE) on Liver Assist. Receives: Device: dual hypothermic oxygenated perfusion (DHOPE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Early Allograft Dysfunction
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
Measured: Day 7 (post operative)
Overall graft survival
Overall graft survival
Measured: Day 180 (post operative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study startJan 2027 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionApr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XVIVO Perfusion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916325
- Sponsor's protocol ID
- LiA-US-001
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No