OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation

TransMedics300 enrolled

Overview

A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.

The OCS™ Liver PROTECT Trial is a two-armed, multicenter, prospective, randomized, controlled pivotal trial to evaluate the effectiveness and safety of the OCS Liver to preserve and assess donor livers intended for transplantation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Liver Transplantation Liver Preservation for Transplant

Interventions

OCS™ Liver SystemDEVICE

ControlOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Registered male or female primary Liver transplant candidate * Age ≥18 years old * Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information Exclusion Criteria: * Acute, fulminant liver failure * Prior solid organ or bone marrow transplant * Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of \>3 mg/dl for \>2 weeks and/or requiring hemodialysis * Multi-organ transplant * Ventilator dependent * Dependent on \> 1 IV inotrope to maintain hemodynamics

Locations (20)

University of California San Diego

La Jolla, California, United States

Scripps

San Diego, California, United States

Outcomes

Primary Outcomes

Participants With Early Liver Allograft Dysfunction (EAD)

Participants with Early liver Allograft Dysfunction (EAD) or primary non-function, defined as presence of one or more of the following criteria: AST level \> 2000 IU/ml within the first 7 postoperative days; Bilirubin ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7; or Primary non-functioning graft within the first 7 days (defined as irreversible graft dysfunction requiring emergency liver re-transplantation or death, in the absence of immunologic or surgical causes)

Time frame: 7 days

Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient

Defined as the average number of LGRSAEs (Liver Graft-Related Serious Adverse Event) up to the 30-day follow-up after transplantation per patient.

Time frame: 30 days

Secondary Outcomes

Patient Survival at Day 30 After Transplant

Patient survival at day 30 after transplantation

Time frame: 30 days after transplant

Patient Survival at Initial Hospital Discharge Post Liver Transplant

Patient survival at initial hospital discharge post liver transplantation

Time frame: at initial hospital discharge post liver transplant, an average of 11 days

Data from ClinicalTrials.gov

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