Clinical trial NCT01963780: International EXPAND Lung Pivotal Trial
Official title: International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Lung For Recruiting, Preserving and Assessing Expanded Criteria Donor Lungs for Transplantation (EXPAND Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplant
Keywords: lung transplantation
lung preservation
breathing lung transplant
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2013-10-16
Enrollment: 79
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
Primary purpose: TREATMENT

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

Detailed description: The OCS™ Lung is to be used to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria from one or more of the following characteristics:

* Donor PaO2/FiO2 ≤ 300 mmHg; or
* Expected ischemic time \> 6 hours; or
* Donor after Cardiac Death (DCD donor); or
* Donor age ≥55 years old

Eligibility criteria: Inclusion Criteria:

* At least one of the following:

  * Donor PaO2/FiO2 ≤ 300 mmHg; or
  * Expected ischemic time \> 6 hours; or
  * Donor after Cardiac Death (DCD donor); or
  * Donor age ≥55 years old

Exclusion Criteria:

* • Presence of moderate to severe traumatic lung injury with air and/or blood leak

  * Presence of confirmed active pneumonia or persistent purulent secretions on repeated bronchoscopy evaluation or ET suction
  * Previous history of pulmonary disease
  * Multiple transfusions of \>10 pRBCs units
  * ABO incompatibility
  * Tobacco history of \>20 pack years

Primary outcomes:
measure: Number of Participants With Composite Endpoint of Patient Survival at Day-30 Post Transplant and Absence of Primary Graft Dysfunction (PGD) Grade 3 During the First 72 Hours Post Lung Transplant
timeFrame: 30 days post lung transplantation
Secondary outcomes:
measure: Number of Participants With ISHLT Primary Graft Dysfunction (PGD) Grade 2 or 3 at T72 Hours Post Lung Transplantation
timeFrame: 72 hours post lung transplantation
measure: Number of Participants With Primary Graft Dysfunction Grade 3 at T72 Hours
timeFrame: 72 hours post lung transplantation
Other outcomes:
measure: Primary Safety Endpoint: Number of Lung Graft Related Serious Adverse Events During the First 30 Days Post Lung Transplantation
timeFrame: 30 days post lung transplantation
measure: Long-term Survival: Survival at 12-months Post-transplant
timeFrame: 12-months
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Atlanta
country: United States
facility: Emory
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Leuven
country: Belgium
facility: University of Leuven Hospital
city: Hannover
country: Germany
facility: Hannover Medical School
city: Madrid
country: Spain
facility: Hospital Universitario Puerta De Hierro
Study officials:
affiliation: University of California, Los Angeles
name: Abbas Ardehali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leuven Medical Center
name: Dirk Van Raemdonck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loor G, Warnecke G, Villavicencio MA, Smith MA, Kukreja J, Ardehali A, Hartwig M, Daneshmand MA, Hertz MI, Huddleston S, Haverich A, Madsen JC, Van Raemdonck D. Portable normothermic ex-vivo lung perfusion, ventilation, and functional assessment with the Organ Care System on donor lung use for transplantation from extended-criteria donors (EXPAND): a single-arm, pivotal trial. Lancet Respir Med. 2019 Nov;7(11):975-984. doi: 10.1016/S2213-2600(19)30200-0. Epub 2019 Aug 1.