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

Organ Preservation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02953483
• Other study ID #: 10735-PG-1Trg-15/4913-14
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2016
• Last updated: October 31, 2016
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Rajarajan Ganesan, MD
• Phone: +919815930510
• Email: raja2n[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Organ Preservation

Intervention

Other:
• Red blood cells
Packed red blood cells to final hematocrit of 14%

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance	Measured from the airway pressure on ventilator	From beginning of perfusion to 4 hours after that	No
Secondary	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	No
Secondary	Pulmonary vascular resistance	Calculated from measured pulmonary artery pressure and pump flow	From beginning of perfusion to 4 hours after that	No
Secondary	Lung injury score	By pathological examination	From beginning of perfusion to 4 hours after that	No