OCS Liver DCD Trial

Not Applicable

Terminated

• Conditions: Liver Transplant
• Interventions: Device: OCS Liver System

• Registration Number: NCT04194437
• Lead Sponsor: TransMedics

Brief Summary

Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.

Detailed Description

To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Study Start: 2020-07-24
• Primary Completion: 2022-03-22
• Status Verified: 2024-11
• Study Completion: 2024-12-16
• Results First Submitted: 2024-12-23
• Results First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Results First Posted: 2025-01-17
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Registered primary liver transplant candidate
• Age ≥ 18 years
• Obtained informed consent

Exclusion Criteria

• Acute, fulminant liver failure
• Prior solid organ or bone marrow transplant
• Ventilator dependent on day of transplant/donor organ offer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OCS Preserved Livers	OCS Liver System	This is a single-arm trial of OCS preserved livers used for transplantation.

Primary Outcome Measures

Name	Time	Method
Liver Graft Survival Through 6 Months Post-transplant	6 months	Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation

Trial Locations

Locations (14)

Tampa General; 🇺🇸 Tampa, Florida, United States

University of San Diego; 🇺🇸 La Jolla, California, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Scripps; 🇺🇸 La Jolla, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Montefiore; 🇺🇸 Bronx, New York, United States

UCSF; 🇺🇸 San Francisco, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

University of Texas Southwest; 🇺🇸 Dallas, Texas, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

University of Texas San Antonio; 🇺🇸 San Antonio, Texas, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States