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

XVIVO

Status: Not yet enrolling

Conditions: Liver Transplantation; Liver Transplant Surgery

Treatments: Device: dual hypothermic oxygenated perfusion (DHOPE)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06916325

LiA-US-001

Details and patient eligibility

About

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.

Enrollment: 215 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Participant 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

Participant 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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215 participants in 1 patient group

Participants requiring liver transplant

Experimental group

Description:

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.

Treatment:

Device: dual hypothermic oxygenated perfusion (DHOPE)