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

Lung Transplant Clinical Trial

— EVLP-CHUM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02235610
• Other study ID #: CE14.100
• Status: Recruiting
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Ahmed Menaouar, PhD
• Phone: 514-890-8000
• Email: ahmed.menaouar.chum[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Transplant

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Fondation Pour La Recherche en Chirurgie Thoracique De Montreal, Institut de Recherches Cliniques de Montreal (IRCM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkers	Measure the concentrations of calgranulin and high mobility group box-1 (HMGB1)	1 hour pre- and up to 30 days post-transplant
Primary	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	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
Secondary	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
Secondary	Duration of mechanical ventilation	How long it takes to disconnect the patient from mechanical ventilation	30 days after lung transplant
Secondary	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
Secondary	90 day Mortality	Patient survival 90 days after lung transplantation	90 days after lung transplant