Ex-Vivo Lung Perfusion to Increase the Number of Organs for Transplantation

Study Overview
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Brief Summary
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The recent introduction of ex-vivo lung perfusion (EVLP) as a tool to evaluate and recondition lungs from marginal donors has opened a new era in the field of lung transplantation.

Detailed Description
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Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving marginal lungs procured from brain death donors and reconditioned by EVLP, with that of subjects receiving lungs procured from standard donors.

Official Title
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Ex-Vivo Lung Perfusion to Improve Donor Lung Function and Increase the Number of Organs Available for Transplantation

Conditions
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Disorder Related to Lung Transplantation, Brain Death, Graft Failure, Primary Graft Dysfunction

Intervention / Treatment
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* Procedure: EVLP Group


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for donor lung: Recipient to undergo single or bilateral Lung Transplantation Donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) below 300 mmHg, or doubtful donor lung function Exclusion criteria for donor lung: Massive lung contusion Aspiration Pneumonia Sepsis 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 |
| --- | --- |
| No Intervention: Standard Group<br>Recipients of lungs procured from brain death donors deemed suitable for transplantation according to standard criteria. Events: lung procurement, cold storage on ice, transplantation. | |
| Experimental: EVLP Group<br>Recipients of marginal lungs procured from brain death donors and reconditioned with ex-vivo lung perfusion (EVLP). Events: lung procurement, cold storage on ice, reconditioning by EVLP, cold storage on ice, transplantation. | Procedure: EVLP Group<br>* EVLP technique: Steen solution; normothermia; low flow, open atrium, low hematocrit. Endpoints of EVLP assessment of lungs suitability: oxygenation, respiratory mechanics, pulmonary vascular resistance, chest X-ray, fibrobronchoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Graft Dysfunction 72 hours after lung transplantation (PGD72) | Primary Graft Dysfunction 72 hours after transplantation (PGD72) definition: grade 3 according to the International Society of Heart and Lung Transplantation classification | 72 hours | 
| 30 day Mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation after transplantation |  | 30 days | 
| ICU length of stay after transplantation |  | 30 days |