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

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

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

Study Overview

• Status: Unknown
• Conditions: Organ Preservation
• Intervention / Treatment: Other: Red blood cells

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 Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Recruiting
    • Postgraduate Institute of Medical Education and Research
    • Contact: Rajarajan Ganesan, M.D; Phone Number: +919815930510; Email: raja2n@gmail.com
    • Contact: Goverdhan D Puri, M.D, Ph.D; Phone Number: +91722755065; Email: gdpuri007@hotmail.com
    • Sub-Investigator: Ashim Das, MD
    • Sub-Investigator: Harkant Singh, MCh
    • Sub-Investigator: Aveek Jayant, MD
    • Sub-Investigator: Kamal Kaajal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acellular first; 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	Other: Red blood cells; Packed red blood cells to final hematocrit of 14%
Experimental: Cellular first; Lung preservative solution will contain red blood cells for the first two hours followed by acellular perfusate for the next two hours	Other: Red blood cells; Packed red blood cells to final hematocrit of 14%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	Measured from the airway pressure on ventilator	From beginning of perfusion to 4 hours after that

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Study Director: Goverdhan D Puri, MD, PhD, Postgraduate Institute of Medical Education and Research

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: October 28, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Ex Vivo lung perfusion
• Other Study ID Numbers: 10735-PG-1Trg-15/4913-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO