OCS Lung System EXPAND II Trial

Not Applicable

Terminated

• Conditions: Lung Transplantation
• Interventions: Device: OCS Lung Preservation

• Registration Number: NCT03343535
• Lead Sponsor: TransMedics

Brief 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.

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 Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-10
• Study First Posted: 2017-11-17
• Study Start: 2018-03-12
• Primary Completion: 2019-08-27
• Study Completion: 2022-07-06
• Status Verified: 2023-11
• Results First Submitted: 2023-12-19
• Results First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-01
• Results First Posted: 2024-02-28
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OCS Preservation	OCS Lung Preservation	-

Primary Outcome Measures

Name	Time	Method
Donor Lung Utilization Rate	Immediately at Transplantation	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.
Patient Survival	30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant	Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later.

Secondary Outcome Measures

Name	Time	Method
Primary Graft Dysfunction Grade 3	72 hours post-transplant	Number of Participants with Primary Graft Dysfunction Grade 3 at T72 hours

Trial Locations

Locations (14)

The Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Baylor St. Luke's Medical Center; 🇺🇸 Houston, Texas, United States

St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Nebraska; 🇺🇸 Omaha, Nebraska, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States