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

NCT ID: NCT06916325

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2032-01-31

Brief 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.

Conditions

Liver Transplant Surgery; Liver Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants requiring liver transplant

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.

Group Type: EXPERIMENTAL

dual hypothermic oxygenated perfusion (DHOPE)

Intervention Type: 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.

Interventions

dual hypothermic oxygenated perfusion (DHOPE)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Participant is able to provide informed consent and HIPAA authorization

2. Age ≥18 years

3. 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

4. Participant is willing to comply with the study requirements and procedures

Exclusion Criteria

1. Participant will undergo concurrent multi-organ transplantations (liver-kidney, liver-lung, etc.)

2. Participant is listed for liver transplantation due to fulminant liver failure (UNOS status 1A)

3. Participant is listed for a repeat liver transplantation (>1 graft)

4. Participant is pregnant

5. 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)

6. Participant is enrolled in an interventional clinical trial with an investigational drug or device

7. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

XVIVO Perfusion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jaya Tiwari

Role: CONTACT

jaya.tiwari@xvivogroup.com

240-758-3818

Other Identifiers

LiA-US-001

Identifier Type: -

Identifier Source: org_study_id