Ex-Vivo Lung Reconditioning

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. Thus, a strategy that could improve the quality and precision of assessment of nonacceptable donor lungs could have a major impact on reducing waiting time and mortality while on the list. A new method for ex vivo lung perfusion (EVLP) has been developed recently by Steen and colleagues to assess the quality of lungs from a non-heart-beating donor. The method can also be used to recondition marginal and nonacceptable donor lungs. After harvesting, the lungs were perfused ex vivo with Steen Solution, an extracellular matrix with high colloid osmotic pressure. A membrane oxygenator connected to the circuit received gas from a mixture of nitrogen and carbon dioxide, maintaining a normal mixed venous blood gas level in the perfusate. The lungs were gradually rewarmed, reperfused, and ventilated for evaluation through analyses of oxygenation capacity, pulmonary vascular resistance (PVR), lung compliance (LC), and biopsy.

Official Title
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Pilot Study of Lung Transplantation After Ex-Vivo Lung Reconditioning

Conditions
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Lung Transplantation

Intervention / Treatment
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* Device: Xvivo Chamber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients on the waiting list for lung transplantation and for which the Biomedicine -Agency has awarded a lung transplantation after Ex-Vivo lung reconditioning Patients affiliated to a social security system; Patients who consented to participate in writing Exclusion Criteria: -Patients under tutorship or unable to consent or institutionalized

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ExVivo lung reconditioning<br> | Device: Xvivo Chamber<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of transplantable grafts and Reduced waiting time before transplantation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of data obtained 2 hours after Ex-Vivo lung reconditioning with those obtained 4 hours after Ex-Vivo lung reconditioning |  | 4 hours after Ex-Vivo lung reconditioning | 
| Number of deaths of patients on waiting list |  | 5 years | 
| survival time after lung transplantation with ExVivo lung reconditioning |  | 1 year after end of study | 
| Quality of life scale score after lung transplantation with ExVivo lung reconditioning |  | 1 year after end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung transplantation, ExVivo reconditionning