International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation (INSPIRE)
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| ClinicalTrials.gov Identifier: NCT01630434 |
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Recruitment Status :
Completed
First Posted : June 28, 2012
Results First Posted : July 7, 2022
Last Update Posted : July 7, 2022
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Sponsor:
TransMedics
Information provided by (Responsible Party):
TransMedics
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Brief Summary:
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Preservation | Device: OCS Lung Device: Cold flush and storage | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 320 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation |
| Study Start Date : | November 2011 |
| Actual Primary Completion Date : | September 2014 |
| Actual Study Completion Date : | April 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: OCS Lung (Treatment Group)
The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs.
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Device: OCS Lung
OCS Lung will be used to preserve the donor lungs (Treatment Group). |
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Active Comparator: Cold flush and storage (Control Group)
Donor lungs will be preserved using cold flush and storage (control group)
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Device: Cold flush and storage
Donor lungs will preserved using standard cold flush and storage
Other Name: Commercially available cold preservation solution |
Primary Outcome Measures :
- 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. [ Time Frame: Day 30 after 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.
Secondary Outcome Measures :
- Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-transplantation [ Time Frame: 72 hours after 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.
- Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-transplantation [ Time Frame: 72 hours after 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.
- Patient Survival at Day 30 [ Time Frame: Day 30 ]
Other Outcome Measures:
- Primary Safety Endpoint: Lung Graft-related Serious Adverse Events (LGRSAEs) Through 30-days Post-transplant Per Subject [ Time Frame: 30 days post-transplant ]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.
- Long-term Survival: 24-month Survival [ Time Frame: 24 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630434
Locations
Show 21 study locations
Sponsors and Collaborators
TransMedics
Investigators
| Study Director: | Abbas Ardehali, MD | Ronald Reagan Medical Center, UCLA | |
| Study Director: | Dirk van Raemodonck, MD | UZ Leuven, Belgium | |
| Study Director: | Gregor Warnecke, MD | Hannover Medical Center, Germany |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | TransMedics |
| ClinicalTrials.gov Identifier: | NCT01630434 |
| Other Study ID Numbers: |
OCS-LUN-03-2010 |
| First Posted: | June 28, 2012 Key Record Dates |
| Results First Posted: | July 7, 2022 |
| Last Update Posted: | July 7, 2022 |
| Last Verified: | May 2016 |