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Use of Ex Vivo Lung Perfusion (EVLP) in Reconditioning Marginal Donor Lungs for Transplantation

NCT ID: NCT02235610

Last Updated: 2023-12-19

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

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2024-12-31

Brief Summary

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The overall objective of this study is to evaluate the clinical effectiveness of the novel technique of donor EVLP in increasing lung transplant activity by allowing previously unusable donor lungs to be safely used in clinical lung transplantation. Furthermore, to utilize the EVLP technique in research settings thus allowing the evaluation of inflammatory molecules (biomarkers) that would benefit a successful pre-conditioning and increase knowledge of the lungs inflammatory response before transplantation.

Detailed Description

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Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques. These lungs will be brought to the study transplant centre to be perfused in our system by the transplant team. Perfusion of these lungs will be performed using evaluation solution with addition of red blood cells cross matched with the recipient, heparin and antibiotics. Those lungs that after perfusion in our system meet the normal transplantation criteria will be considered for transplantation. Lungs will be excluded for transplantation if the organs don't meet the normal transplantation criteria.

Conditions

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Lung Transplant

Keywords

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Lung Transplantation Ex Vivo Lung Perfusion EVLP

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Standard Group

Recipients receive standard donor lungs as per current clinical practice.

No experimental procedures will be carried out.

Group Type NO_INTERVENTION

No interventions assigned to this group

EVLP Group

Recipients receive reconditioned EVLP donor lungs and current standard of care for lung transplant is administered.

Group Type EXPERIMENTAL

EVLP Group

Intervention Type PROCEDURE

EVLP technique (Lund Protocol): open left atrium, Steen solution mixed with red blood cells and perfusion 100% of the donor predicted cardiac output.

Lungs with good and stable function during EVLP will be transplanted into recipients as per current clinical practice.

Interventions

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EVLP Group

EVLP technique (Lund Protocol): open left atrium, Steen solution mixed with red blood cells and perfusion 100% of the donor predicted cardiac output.

Lungs with good and stable function during EVLP will be transplanted into recipients as per current clinical practice.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult patients (aged 18 years and over).
* Patients already on or added to the active waiting list for first lung transplant.
* Patients providing informed consent for participation in the study at the time of study commencement or time of listing for transplant.
* Patients' re-confirmation informed consent for the study on the day of the lung transplant.

Exclusion Criteria

* Patients aged less than 18 years.
* Patients not providing informed consent for the study.
* Patients not in possession of patient information sheets for the study prior to the day of lung transplant.
* Patients' not re-confirming consent for the study on the day of lung transplant.
* Patients requiring invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO) support.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Pour La Recherche en Chirurgie Thoracique De Montreal

UNKNOWN

Sponsor Role collaborator

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

OTHER

Sponsor Role collaborator

Institut de Recherches Cliniques de Montreal (IRCM)

UNKNOWN

Sponsor Role collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pasquale Ferraro, MD

Role: PRINCIPAL_INVESTIGATOR

CHUM

Locations

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Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Ahmed Menaouar, PhD

Role: CONTACT

Phone: 514-890-8000

Email: [email protected]

Basil Nasir, MD

Role: CONTACT

Phone: 514-890-8000

Email: [email protected]

Facility Contacts

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Ahmed Menaouar, PhD

Role: primary

Basil Nasir, MD

Role: backup

Other Identifiers

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CE14.100

Identifier Type: -

Identifier Source: org_study_id