NCT02953483

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 2, 2016

Status Verified

October 1, 2016

Enrollment Period

8 months

First QC Date

October 28, 2016

Last Update Submit

October 31, 2016

Conditions

Organ Preservation

Keywords

Ex Vivo lung perfusion

Outcome Measures

Primary Outcomes (1)

  • Compliance

    Measured from the airway pressure on ventilator

    From beginning of perfusion to 4 hours after that

Secondary Outcomes (3)

  • Partial pressure to Inspired oxygen concentration ratio

    From beginning of perfusion to 4 hours after that

  • Pulmonary vascular resistance

    From beginning of perfusion to 4 hours after that

  • Lung injury score

    From beginning of perfusion to 4 hours after that

Study Arms (2)

Acellular first

EXPERIMENTAL

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

Cellular first

EXPERIMENTAL

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

Red blood cellsOTHER

Packed red blood cells to final hematocrit of 14%

Acellular firstCellular first

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

RECRUITING

Related 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.

    PMID: 21488765BACKGROUND

  • 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.

    PMID: 22975103BACKGROUND

MeSH Terms

Interventions

Erythrocyte Count

Intervention Hierarchy (Ancestors)

Blood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Goverdhan D Puri, MD, PhD

    Post Graduate Institute of Medical Education and Research, Chandigarh

    STUDY DIRECTOR

Central Study Contacts

Rajarajan Ganesan, MD

CONTACT

+919815930510raja2n@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior resident

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 2, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 2, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)