Ex Vivo Lung Perfusion : Effect of Cellular Perfusate on Mechanical Properties and Gas Exchange Function of Donor Lungs

Study Overview
=================
Brief Summary
-----------------
The lungs retrieved from the brain dead multi organ donor will be placed in a lab . They will be connected to a ventilator and preservative solution will be circulated through it . Blood will be added to the fluid depending on the group to which the lungs are allocated and its effects on lung function will be seen

Detailed Description
-----------------
The lungs of a brain dead multi organ donor will be retrieved according to standard protocol. Once a decision is made not to transplant the lungs either because of not satisfying ideal criteria or in the absence of a potential recipient they will be included in the study.They will be ventilated optimally and connected to a cardiopulmonary bypass machine for circulating preservative solution through it . Red blood cells will be added to the solution either initially or later depending on the group to which it is allocated .Monitoring of mechanical and gas exchange function and pathological examination of the lungs will be performed at various time points to observe the effect of red blood cells. The lungs will be properly discarded at the end of the procedure and will not be used for transplantation.

Official Title
-----------------
Ex Vivo Lung Perfusion : Evaluating the Effect of Cellular Perfusate on Mechanical Properties and Gas Exchange Function of the Donor Lungs : A Randomised Cross Over Study

Conditions
-----------------
Organ Preservation

Intervention / Treatment
-----------------
* Other: Red blood cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Brain death certified multi organ donor Absence of ideal lung donor criteria or absence of suitable lung recipient Exclusion Criteria: presence of severe mechanical lung injury on visual inspection or radiography Presence of pneumonia Positive serology ( Hepatitis B,C and HIV

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acellular first<br>Lung preservative solution without red blood cells will be used for perfusion in the initial 2 hours followed by addition of red blood cells for the next two hours | Other: Red blood cells<br>* Packed red blood cells to final hematocrit of 14%<br>|
| Experimental: Cellular first<br>Lung preservative solution will contain red blood cells for the first two hours followed by acellular perfusate for the next two hours | Other: Red blood cells<br>* Packed red blood cells to final hematocrit of 14%<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | Measured from the airway pressure on ventilator | From beginning of perfusion to 4 hours after that | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial pressure to Inspired oxygen concentration ratio | Ratio of partial pressure of oxygen in perfusate to fraction of inspired oxygen | From beginning of perfusion to 4 hours after that | 
| Pulmonary vascular resistance | Calculated from measured pulmonary artery pressure and pump flow | From beginning of perfusion to 4 hours after that | 
| Lung injury score | By pathological examination | From beginning of perfusion to 4 hours after that | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ex Vivo lung perfusion