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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Unknown

Conditions: Organ Preservation

Treatments: Other: Red blood cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02953483

10735-PG-1Trg-15/4913-14

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Acellular first

Experimental group

Description:

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

Treatment:

Other: Red blood cells

Cellular first

Experimental group

Description:

Lung preservative solution will contain red blood cells for the first two hours followed by acellular perfusate for the next two hours

Treatment:

Other: Red blood cells