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

NCT02235610 | Unknown DMC

• 1 other identifier: CE14.100
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Lung Transplantation; Ex Vivo Lung Perfusion; EVLP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evaluate primary graft dysfunction (PGD)

  6h, 12h, 24h, 48h and 72h post-transplant

• Duration of hospital stay

  Expected average of 6 weeks

• Duration of mechanical ventilation

  30 days after lung transplant

• Quality of life (QoL) questionnaire

  The day that patients are added to transplant list, at 90 days and 1 year post transplantation

• 90 day Mortality

  90 days after lung transplant

Other Outcomes (1)

• Biomarkers

  1 hour pre- and up to 30 days post-transplant

Study Arms (2)

Standard Group

NO INTERVENTION

Recipients receive standard donor lungs as per current clinical practice. No experimental procedures will be carried out.

EVLP Group

EXPERIMENTAL

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

Procedure: EVLP Group

Interventions

EVLP Group 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.

EVLP Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Fondation Pour La Recherche en Chirurgie Thoracique De Montreal: collaborator
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator
• Institut de Recherches Cliniques de Montreal (IRCM): collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Study Officials

• Pasquale Ferraro, MD

  CHUM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Menaouar, PhD

CONTACT

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

Basil Nasir, MD

CONTACT

514-890-8000; basilsnair@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: September 10, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

CA (1)