Clinical trial NCT02953483: Ex Vivo Lung Perfusion : Effect of Cellular Perfusate on Mechanical Properties and Gas Exchange Function of Donor Lungs
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Organ Preservation
Keywords: Ex Vivo lung perfusion
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2016-11-02
Enrollment: 6
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Compliance
timeFrame: From beginning of perfusion to 4 hours after that
Secondary outcomes:
measure: Partial pressure to Inspired oxygen concentration ratio
timeFrame: From beginning of perfusion to 4 hours after that
measure: Pulmonary vascular resistance
timeFrame: From beginning of perfusion to 4 hours after that
measure: Lung injury score
timeFrame: From beginning of perfusion to 4 hours after that
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
Study officials:
affiliation: PGIMER
name: Goverdhan D Puri, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Cypel M, Yeung JC, Liu M, Anraku M, Chen F, Karolak W, Sato M, Laratta J, Azad S, Madonik M, Chow CW, Chaparro C, Hutcheon M, Singer LG, Slutsky AS, Yasufuku K, de Perrot M, Pierre AF, Waddell TK, Keshavjee S. Normothermic ex vivo lung perfusion in clinical lung transplantation. N Engl J Med. 2011 Apr 14;364(15):1431-40. doi: 10.1056/NEJMoa1014597.
citation: Yeung JC, Cypel M, Machuca TN, Koike T, Cook DJ, Bonato R, Chen M, Sato M, Waddell TK, Liu M, Slutsky AS, Keshavjee S. Physiologic assessment of the ex vivo donor lung for transplantation. J Heart Lung Transplant. 2012 Oct;31(10):1120-6. doi: 10.1016/j.healun.2012.08.016.