Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation

Study Overview
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Brief Summary
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The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for donor lungs that fail to meet standard acceptability criteria. This advanced assessment might lead to increased utilization rates of donor lungs and improved outcomes after lung transplantation.

Detailed Description
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Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques. These lungs will be brought to the study transplant center to be re-assessed by the transplant team. The lungs will be physiologically assessed during ex vivo perfusion with Steen Solution. Perfusion of these lungs will be performed using Steen solution with the addition of methylprednisolone, heparin and antibiotics. With respect to the decision of lung utilization those organs with a delta pO2 (Δ pO2 = Pulmonary vein pO2 - pulmonary artery pO2) during ex vivo perfusion assessment > 350mmHg, good lung compliance, and a favorable opinion of the transplant surgeon will be considered transplantable. Lungs will be excluded for transplantation: if the Δ pO2 is less than 350mmHg or if they demonstrate >10% deterioration in any of the following functional parameters: pulmonary vascular resistance (PVR), dynamic compliance or airway pressures. Lungs will also be excluded if they are deemed unsuitable based on the clinical judgment of the lung transplant surgeon.

Official Title
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Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation

Conditions
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Lung Transplantation

Intervention / Treatment
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* Drug: Ex vivo lung perfusion with Steen Solution™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for donor lung: Recipient to undergo a single or bilateral Lung Transplantation Last donor PaO2/FiO2 ≤ 300mmHg Poor oxygenation and/or poor lung compliance is the primary reason for unsuitability Absence of pneumonia, persistent purulent secretion on bronchoscopy or significant mechanical trauma Exclusion Criteria: Infection Aspiration Significant mechanical lung injury - contusion Infectious diseases : HIV, Hepatitis B and C, HTLV & Syphilis Malignancy

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVLP Group<br>EVLP Group are those recipient lung transplant patients that received donor lungs that had been placed on the ex vivo lung perfusion system with Steen Solution™ . | Drug: Ex vivo lung perfusion with Steen Solution™<br>* The circuit is primed with 2,000cc Steen Solution™. At one hour of EVLP, 500 cc of circulated perfusate was removed and replenished with 500 cc of fresh perfusate. After that, 250 cc of perfusate was exchanged every hour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PGD scores in the first 72 hours after lung transplantation. | Immediate lung function is one of the key factors in determining the impact of donor lung quality, therefore the PGD score within 72 hrs was selected as the primary endpoint. | 72 hours | 
| 30 day Mortality | Mortality at 30 days post transplant | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extra-corporeal membrane oxygenation use | If the patient needed to be placed on extra-corporeal membrane oxygenation after transplantation. | 30 days | 
| Bronchial complications | To see if there was an increased risk for bronchial complications | 30 days | 
| Ventilator duration | How long was the patient on the ventilator after lung transplantation and was there an increased time on ventilator for the patient after EVLP. | 30 days | 
| Intensive Care Unit length of stay |  | 30 days | 
| Hospital length of stay | Time in the hospital | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung, Transplantation, Lung Transplantation, Transplantation Lung