Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion

Study Overview
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Brief Summary
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Only about 15% of the potential candidates for lung donation are considered suitable for transplantation. A new method for ex vivo lung perfusion (EVLP) has been developed and can be used for evaluation and reconditioning of marginal and unacceptable lungs. The ´purpose of this study is to analyse the executability and safety of ex vivo lung perfusion pulmonary ex vivo in marginal donors.

Detailed Description
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Donor Inclusion criteria: Age < 55 years-old; Smoking history < 20 pack-year; Clear chest radiograph; Absence of significant chest trauma; Absence of purulent secretions and gastric contents at bronchoscopy; PaO2 < 300 mm Hg (FIO2 1.0, PEEP 5 cmH2O) Exclusion criteria: Lungs presenting PO2 < 400 mmHg after ex vivo lung perfusion

Official Title
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Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion

Conditions
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Respiratory Tract Diseases

Intervention / Treatment
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* Procedure: Ex vivo lung transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age < 55 years-old; Smoking history < 20 pack-year; Clear chest radiograph; Absence of significant chest trauma; Absence of purulent secretions and gastric contents at bronchoscopy; PaO2 < 300 mm Hg (FIO2 1.0, PEEP 5 cmH2O) Exclusion Criteria: Lungs presenting PO2 < 400 mmHg after ex vivo lung perfusion

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 70 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: Ex vivo lung transplantation<br>single-group studies | Procedure: Ex vivo lung transplantation<br>* Evaluation and reconditioning of lungs following lung transplantation<br>* Other names: Non applicable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-days mortality |  | 30 days after ex vivo lung transplantation | 
| Respiratory complications (primary graft dysfunction, infection, rejection, bronchiolitis obliterates syndrome) |  | 30 days after the ex vivo lung transplantation | 
| 12-months survival |  | 12 months survival after ex vivo lung transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation index (PaO2/FiO2)on ICU arrival and 72 hours |  | 72 hours after ex vivo lung transplantation | 
| Mechanical ventilation time |  | 30 days after ex vivo lung transplantation | 
| Hospital and ICU time of stay |  | 12 months after ex vivo lung transplantation | 
| Non-respiratory complications (arrhythmia, renal failure, sepsis) |  | 30 days after ex vivo lung transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystic fibrosis, chronic obstructive pulmonary disease, pulmonary fibrosis