OCS Lung System EXPAND II Trial

Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation

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.

Study Overview

• Status: Terminated
• Conditions: Lung Transplantation
• Intervention / Treatment: Device: OCS Lung Preservation

Detailed Description

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
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital and Medical Center
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist
    • Houston, Texas, United States, 77030
      • Baylor St. Luke's Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OCS Preservation	Device: OCS Lung Preservation; OCS Lung Preservation; Other Names: OCS Lung Transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately at Transplantation
Patient Survival	Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later.	30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Graft Dysfunction Grade 3	Number of Participants with Primary Graft Dysfunction Grade 3 at T72 hours	72 hours post-transplant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Lung Graft-related Serious Adverse Events	Number of lung graft-related serious adverse events through the 30-day follow-up or until initial hospital admission (if longer than 30 days) after transplantation per subject.	30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant

Collaborators and Investigators

• Sponsor: TransMedics

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): August 27, 2019
• Study Completion (Actual): July 6, 2022

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 10, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: breathing lung transplant; portable ex-vivo lung perfusion; portable OCS Lung System
• Other Study ID Numbers: OCS-LUN-012017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes