Organ Preservation
Conditions
Keywords
Ex Vivo lung perfusion
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.
Interventions
OTHERRed blood cells
Packed red blood cells to final hematocrit of 14%
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance | From beginning of perfusion to 4 hours after that | Measured from the airway pressure on ventilator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partial pressure to Inspired oxygen concentration ratio | From beginning of perfusion to 4 hours after that | Ratio of partial pressure of oxygen in perfusate to fraction of inspired oxygen |
| Pulmonary vascular resistance | From beginning of perfusion to 4 hours after that | Calculated from measured pulmonary artery pressure and pump flow |
| Lung injury score | From beginning of perfusion to 4 hours after that | By pathological examination |
Countries
India
Contacts
Primary ContactRajarajan Ganesan, MD
Outcome results
None listed