International EXPAND Lung Pivotal Trial

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Lung Transplant

Intervention / Treatment
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* Device: OCS Lung Preservation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCS Lung Tx.<br>A prospective, pivotal single arm trial. | Device: OCS Lung Preservation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung transplantation, lung preservation, breathing lung transplant