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

Launched by XVIVO PERFUSION · Mar 31, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to preserve liver organs from deceased donors before they are transplanted into patients. The method being tested is called dual hypothermic oxygenated perfusion (DHOPE), which helps keep the liver healthy and functioning better for a successful transplant. The goal of the study is to confirm that this method is safe and effective for future liver transplant surgeries.

To participate in the trial, you need to be at least 18 years old and be registered as a first-time liver transplant candidate on the United Network for Organ Sharing (UNOS) waiting list. This means that you are waiting for a liver transplant because of liver-related conditions, and if you have a specific type of liver cancer, it must meet certain criteria. If you meet these requirements and are willing to follow the study's procedures, you may be eligible to join. Participants will be closely monitored throughout the process, and it’s important to know that individuals with certain medical conditions or those undergoing other organ transplants will not be eligible for this study.

Gender

ALL

Eligibility 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