OCS Liver DCD Trial

TransMedics

Status: Terminated

Conditions: Liver Transplant

Treatments: Device: OCS Liver System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04194437

OCS-LVR-092019

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

OCS Preserved Livers

Experimental group

Description:

This is a single-arm trial of OCS preserved livers used for transplantation.

Treatment:

Device: OCS Liver System