CClinicalTrials.gg
Status unknownNCT02953483Updated Nov 2, 2016

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

An interventional study of Red blood cells in Organ Preservation, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Status unknown at 1 site in India. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
16 Years to 70 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Organ Preservation

Keywords

  • Ex Vivo lung perfusion
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In context

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Brain death certified multi organ donor
  • Absence of ideal lung donor criteria or absence of suitable lung recipient

Exclusion criteria

Exclusion Criteria:

  • presence of severe mechanical lung injury on visual inspection or radiography
  • Presence of pneumonia
  • Positive serology ( Hepatitis B,C and HIV
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherRed blood cells

    Packed red blood cells to final hematocrit of 14%

06

What researchers measure

Primary outcomes

  1. Compliance

    Measured from the airway pressure on ventilator

    Time frame: From beginning of perfusion to 4 hours after that

Secondary outcomes

  1. Partial pressure to Inspired oxygen concentration ratio

    Ratio of partial pressure of oxygen in perfusate to fraction of inspired oxygen

    Time frame: From beginning of perfusion to 4 hours after that

  2. Pulmonary vascular resistance

    Calculated from measured pulmonary artery pressure and pump flow

    Time frame: From beginning of perfusion to 4 hours after that

  3. Lung injury score

    By pathological examination

    Time frame: From beginning of perfusion to 4 hours after that

07

Study locations

1 of 1 sites recruiting
  • Postgraduate Institute of Medical Education and Research
    Chandigarh, 160012, India
    • Rajarajan Ganesan, M.D · Contact · raja2n@gmail.com · +919815930510
    • Goverdhan D Puri, M.D, Ph.D · Contact · gdpuri007@hotmail.com · +91722755065
    • Ashim Das, MD · Sub investigator
    • Harkant Singh, MCh · Sub investigator
    • Aveek Jayant, MD · Sub investigator
    • Kamal Kaajal, MD · Sub investigator
    Recruiting
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References and documents

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. PubMed 21488765 ↗
  • 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. PubMed 22975103 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02953483
Lead sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Responsible party
Rajarajan Ganesan (Senior resident, Post Graduate Institute of Medical Education and Research, Chandigarh) — Principal investigator
First posted
Nov 2, 2016
Start date
Oct 2016
Primary completion
Jun 2017 (estimated)
Completion
Jun 2017 (estimated)
Last update
Nov 2, 2016

Study contacts

Rajarajan Ganesan, MD
Contact
raja2n@gmail.com
+919815930510
Goverdhan D Puri, MD, PhD
study director · PGIMER

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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