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Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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

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

NCT06916325•XVIVO Perfusion

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

July 1, 2025

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2032

Last Updated

April 8, 2025

Enrollment

215

ESTIMATED participants

Conditions

Liver Transplant SurgeryLiver Transplantation

Interventions

dual hypothermic oxygenated perfusion (DHOPE)

DEVICE

Contacts

Jaya Tiwari

CONTACT

240-758-3818 jaya.tiwari@xvivogroup.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Rectus-Intercostal Fascial Plane Block for Liver Transplantation Donors

HOPE Against Cancer Recurrence in HCC

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