Recruiting

Ex Vivo Lung Perfusion

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT02235610

Conditions

Lung Transplant

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

EVLP Group

Study Details

Brief summary:

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.

Conditions

Lung Transplant

Study ID

NCT02235610

Start date

Oct, 2014

Status verified date

Dec, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

no intervention: Standard Group

Recipients receive standard donor lungs as per current clinical practice.

No experimental procedures will be carried out.

experimental: EVLP Group

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

Interventions

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.

Primary outcome measure

  • Measure of survival [ Time Frame: 12 months after transplantation ]

Central Contacts and Locations

Central contacts

Ahmed Menaouar, PhD

514-890-8000ahmed.menaouar.chum@ssss.gouv.qc.ca

Basil Nasir, MD

514-890-8000basilsnair@gmail.com

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Ahmed Menaouar, PhD

514-890-8000ahmed.menaouar.chum@ssss.gouv.qc.ca

Basil Nasir, MD

514-890-8000basilsnasir@gmail.com

Principal Investigator:

Pasquale Ferraro, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Dec 19, 2023

Last verified

Dec, 2023

Keywords

  • Lung Transplantation
  • Ex Vivo Lung Perfusion
  • EVLP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2023-12-19.