Lung Preservation Clinical Trial
— INSPIREOfficial title:
Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation
| Verified date | May 2016 |
| Source | TransMedics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).
| Status | Completed |
| Enrollment | 320 |
| Est. completion date | April 2016 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Registered primary double-lung transplant candidate - Age > or equal to 18 - 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 - Multiple organ transplant recipient - Chronic use of hemodialysis or diagnosis of chronic renal insufficiency |
| Country | Name | City | State |
|---|---|---|---|
| Australia | St. Vincent's Hospital | Darlinghurst | New South Wales |
| Belgium | Hospitals Leuven | Leuven | |
| Canada | University of Alberta | Edmonton | Alberta |
| France | University Hospitals of Marseille | Marseille | |
| France | Groupe Hospitalier Hopitaux Universitaries | Paris | |
| France | N.H.C Hospital Civil | Strasbourg | |
| Germany | German Heart Institute Berlin | Berlin | |
| Germany | Universitäres Herzzentrum Hamburg GmbH | Hamburg | |
| Germany | Hannover Medical School | Hannover | |
| Italy | University of Padua | Padua | |
| Spain | University Puerta de Hierro Hospital | Madrid | |
| United Kingdom | Papworth Hospital | Cambridge | |
| United Kingdom | Harefield Hospital | Middlesex | |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Indiana University | Indianapolis | Indiana |
| United States | University of California at Los Angeles | Los Angeles | California |
| United States | University of Minnesota | Minneapolis | Minnesota |
| United States | St. Joseph's Hospital and Medical Center | Phoenix | Arizona |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | University of California at San Francisco | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| TransMedics |
United States, Australia, Belgium, Canada, France, Germany, Italy, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Primary Safety Endpoint: Lung Graft-related Serious Adverse Events (LGRSAEs) Through 30-days Post-transplant Per Subject | 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-transplant | |
| Other | Long-term Survival: 24-month Survival | 24 months | ||
| Primary | A Composite of Patient Survival at Day 30 Post Transplantation, and Absence of International Society for Heart & Lung Transplantation (ISHLT) Primary Graft Dysfunction (PGD3) Grade 3 Within the First 72 Hours Post-transplantation. | This composite is a single outcome measure. 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. | Day 30 after transplantation | |
| Secondary | Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-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 after transplantation | |
| Secondary | Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-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 after transplantation | |
| Secondary | Patient Survival at Day 30 | Day 30 |