OCS Lung System EXPAND II Trial

TransMedics46 enrolled

Overview

To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

Inclusion At least one of the following: * Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or * Expected cross-clamp time \> 6 hours for the second lung; or * Donor after Cardiac Death (DCD donor); or * Donor age ≥ 55 years old

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Transplantation

Interventions

OCS Lung PreservationDEVICE

OCS Lung Preservation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female primary double lung transplant candidate * Age ≥ 18 years old * Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information Exclusion Criteria: * Prior solid organ or bone marrow transplant * Single lung recipient * Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis * Participant in any other clinical or investigational trials/programs

Locations (14)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

UCLA Medical Center

Los Angeles, California, United States

University of California, San Francisco

Outcomes

Primary Outcomes

Patient Survival

Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later.

Time frame: 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant

Donor Lung Utilization Rate

Donor lung utilization rate, defined as the number of donated lungs instrumented on OCS™ that meet inclusion/exclusion criteria for the trial and acceptance criteria for transplantation after OCS™ Lung assessment divided by the total eligible donor lungs instrumented on the OCS™ Lung System.

Time frame: Immediately at Transplantation

Secondary Outcomes

Primary Graft Dysfunction Grade 3

Number of Participants with Primary Graft Dysfunction Grade 3 at T72 hours

Time frame: 72 hours post-transplant

Data from ClinicalTrials.gov

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