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

NCT ID: NCT02953483

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Organ Preservation

Keywords

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Ex Vivo lung perfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Red blood cells

Intervention Type OTHER

Packed red blood cells to final hematocrit of 14%

Cellular first

Lung preservative solution will contain red blood cells for the first two hours followed by acellular perfusate for the next two hours

Group Type EXPERIMENTAL

Red blood cells

Intervention Type OTHER

Packed red blood cells to final hematocrit of 14%

Interventions

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Red blood cells

Packed red blood cells to final hematocrit of 14%

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Rajarajan Ganesan

Senior resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Goverdhan D Puri, MD, PhD

Role: STUDY_DIRECTOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

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Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Rajarajan Ganesan, MD

Role: CONTACT

Phone: +919815930510

Email: [email protected]

Facility Contacts

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Rajarajan Ganesan, M.D

Role: primary

Goverdhan D Puri, M.D, Ph.D

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 21488765 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22975103 (View on PubMed)

Other Identifiers

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10735-PG-1Trg-15/4913-14

Identifier Type: -

Identifier Source: org_study_id