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

Clinical Trial of Ex Vivo Lung Perfusion (EVLP) for the Reconditioning of Marginal Donor Lungs for Transplantation.

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Transplant
• Intervention / Treatment: Procedure: EVLP Group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Menaouar, PhD; Phone Number: 30785 514-890-8000; Email: ahmed.menaouar.chum@ssss.gouv.qc.ca
• Study Contact Backup: Name: Basil Nasir, MD; Phone Number: 26275 514-890-8000; Email: basilsnair@gmail.com

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Recruiting
      • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Contact: Ahmed Menaouar, PhD; Phone Number: 30785 514-890-8000; Email: ahmed.menaouar.chum@ssss.gouv.qc.ca
      • Contact: Basil Nasir, MD; Phone Number: 26275 514-890-8000; Email: basilsnasir@gmail.com
      • Principal Investigator: Pasquale Ferraro, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of survival	To measure survival 12 months after transplantation in recipients of EVLP assessed and reconditioned donor lungs (treatment group), compared to that of recipients of standard donor lungs (control group), in order to assess whether survival in the EVLP treatment group over that period is non-inferior to that in the standard control group	12 months after transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate primary graft dysfunction (PGD)	PGD is a clinical entity that reflects the development of early acute lung injury after lung transplantation. PGD severity is graded between 0 and 3 and it is measured at 6h, 12h, 24h, 48h and 72 hours after lung transplantation	6h, 12h, 24h, 48h and 72h post-transplant
Duration of hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 6 weeks	Expected average of 6 weeks
Duration of mechanical ventilation	How long it takes to disconnect the patient from mechanical ventilation	30 days after lung transplant
Quality of life (QoL) questionnaire	Questions about Health and Well-Being of patient after lung transplantation	The day that patients are added to transplant list, at 90 days and 1 year post transplantation
90 day Mortality	Patient survival 90 days after lung transplantation	90 days after lung transplant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers	Measure the concentrations of calgranulin and high mobility group box-1 (HMGB1)	1 hour pre- and up to 30 days post-transplant

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Fondation Pour La Recherche en Chirurgie Thoracique De Montreal; Centre de Recherche du Centre Hospitalier de l'Université de Montréal; Institut de Recherches Cliniques de Montreal (IRCM)
• Investigators: Principal Investigator: Pasquale Ferraro, MD, CHUM

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 25, 2014
• First Submitted That Met QC Criteria: September 9, 2014
• First Posted (Estimated): September 10, 2014

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Lung Transplantation; Ex Vivo Lung Perfusion; EVLP
• Other Study ID Numbers: CE14.100