International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation

Study Overview
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Brief Summary
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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).

Official Title
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Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation

Conditions
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Lung Preservation

Intervention / Treatment
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* Device: OCS Lung
* Device: Cold flush and storage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCS Lung (Treatment Group)<br>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. | Device: OCS Lung<br>* OCS Lung will be used to preserve the donor lungs (Treatment Group).<br>|
| Active Comparator: Cold flush and storage (Control Group)<br>Donor lungs will be preserved using cold flush and storage (control group) | Device: Cold flush and storage<br>* Donor lungs will preserved using standard cold flush and storage<br>* Other names: Commercially available cold preservation solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Patient Survival at Day 30 |  | Day 30 |