OCS Lung System EXPAND II Trial

Lung Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03343535
• Other study ID #: OCS-LUN-012017
• Status: Terminated
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: July 6, 2022

Study information

• Verified date: November 2023
• Source: TransMedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: July 6, 2022
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Device:
• OCS Lung Preservation
OCS Lung Preservation

Locations

Country	Name	City	State
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor St. Luke's Medical Center	Houston	Texas
United States	Houston Methodist	Houston	Texas
United States	UCLA Medical Center	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of Nebraska	Omaha	Nebraska
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	University of California, San Francisco	San Francisco	California
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
TransMedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Secondary	Primary Graft Dysfunction Grade 3	Number of Participants with Primary Graft Dysfunction Grade 3 at T72 hours	72 hours post-transplant