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

Not Applicable

• Conditions: Organ Preservation
• Interventions: Other: Red blood cells

• Registration Number: NCT02953483
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-10-31
• Last Update Submitted: 2016-10-31
• Study First Posted: 2016-11-02
• Last Update Posted: 2016-11-02
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acellular first	Red blood cells	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
Cellular first	Red blood cells	Lung preservative solution will contain red blood cells for the first two hours followed by acellular perfusate for the next two hours

Primary Outcome Measures

Name	Time	Method
Compliance	From beginning of perfusion to 4 hours after that	Measured from the airway pressure on ventilator

Secondary Outcome Measures

Name	Time	Method
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
Lung injury score	From beginning of perfusion to 4 hours after that	By pathological examination
Pulmonary vascular resistance	From beginning of perfusion to 4 hours after that	Calculated from measured pulmonary artery pressure and pump flow

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India