Lung Transplant Clinical Trial
— EXPANDLungOfficial 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)
NCT number | NCT01963780 |
Other study ID # | OCS-LUN-012013 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2013 |
Est. completion date | April 2018 |
Verified date | April 2018 |
Source | TransMedics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 79 |
Est. completion date | April 2018 |
Est. primary completion date | November 22, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University of Leuven Hospital | Leuven | |
Germany | Hannover Medical School | Hannover | |
Spain | Hospital Universitario Puerta De Hierro | Madrid | |
United States | Emory | Atlanta | Georgia |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Duke University | Durham | North Carolina |
United States | University of California at Los Angeles | Los Angeles | California |
United States | University of Minnesota | Minneapolis | Minnesota |
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 |
Lead Sponsor | Collaborator |
---|---|
TransMedics |
United States, Belgium, Germany, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Primary Safety Endpoint: Number of Lung Graft Related Serious Adverse Events During the First 30 Days Post Lung Transplantation | An LGRSAE event is defined as the occurrence of any of the following four categories of adverse events that are also serious; acute rejection, respiratory failure, bronchial anastomotic complication, and major pulmonary-related infection. | 30 days post lung transplantation | |
Other | Long-term Survival: Survival at 12-months Post-transplant | Survival outcomes were collected through one year post-transplant. | 12-months | |
Primary | 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 | Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome. | 30 days post lung transplantation | |
Secondary | Number of Participants With ISHLT Primary Graft Dysfunction (PGD) Grade 2 or 3 at T72 Hours Post Lung Transplantation | Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome. | 72 hours post lung transplantation | |
Secondary | Number of Participants With Primary Graft Dysfunction Grade 3 at T72 Hours | Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome. | 72 hours post lung transplantation |
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