EVLP to Evaluate the Eligibility for Transplantation of DCD-Lungs

Study Overview
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Brief Summary
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The procurement of organs from donors after cardiocirculatory death (DCD) is an accepted strategy to increase organ supply.

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

Official Title
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Extracorporeal Lung Perfusion and Ventilation to Evaluate the Eligibility for Transplantation of Lungs Retrieved From Donors After Cardio-circulatory Death (DCD)

Conditions
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Disorders Related to Lung Transplantation, Graft Failure

Intervention / Treatment
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* Procedure: EVLP-DCD Group


Participation Criteria
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Eligibility Criteria
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Lung donors: subjects with brain death according to neurological or cardiocirculatory criteria age below 65 yrs absence of massive lung contusion, aspiration, pneumonia, sepsis absence of infection, malignancy Recipients: subjects to undergo single or bilateral lung transplantation informed consent to participate in the study

Ages Eligible for Study
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Minimum Age: 15 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Group<br>Recipients of lungs procured from brain dead donors. | |
| Active Comparator: EVLP-DCD Group<br>Recipients of lungs procured from DCD donors, reconditioned/evaluated by EVLP | Procedure: EVLP-DCD Group<br>* Events: application of an open lung protective ventilatory strategy (recruitment manoeuvre, low volume-low frequency ventilation-high PEEP) to the DCD donors; procurement of lungs and cold storage on ice; reconditioning/evaluation by EVLP to assess suitability for transplantation; cold storage on ice; transplantation. Endpoints of 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 |
| --- | --- | --- |
| 30 Day Mortality and Graft Survival | 30 day mortality and graft survival is used as a standard research measure to evaluate post transplant outcome | 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 | 
| Primary Graft Dysfunction 72 hours After Transplantation | Primary Graft Dysfunction 72 hours after transplantation definition: grade 3 according to the International Society of Heart and Lung Transplantation classification | 72 hours |