Clinical trial NCT03343535: OCS Lung System EXPAND II 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Transplantation
Keywords: portable ex-vivo lung perfusion
breathing lung transplant
portable OCS Lung System
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: OCS Lung System
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Patient Survival
timeFrame: 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant
measure: Donor Lung Utilization Rate
timeFrame: Immediately at Transplantation
Secondary outcomes:
measure: Primary Graft Dysfunction Grade 3
timeFrame: 72 hours post-transplant
Other outcomes:
measure: Number of Lung Graft-related Serious Adverse Events
timeFrame: 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: