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

Not Applicable

Recruiting

• Conditions: Lung Transplant
• Interventions: Procedure: EVLP Group

• Registration Number: NCT02235610
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

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 Timeline

• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-10
• Study Start: 2014-10
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Measure of survival	12 months after transplantation	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

Secondary Outcome Measures

Name	Time	Method
Duration of hospital stay	Expected average of 6 weeks	Participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Evaluate primary graft dysfunction (PGD)	6h, 12h, 24h, 48h and 72h post-transplant	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
90 day Mortality	90 days after lung transplant	Patient survival 90 days after lung transplantation
Duration of mechanical ventilation	30 days after lung transplant	How long it takes to disconnect the patient from mechanical ventilation
Quality of life (QoL) questionnaire	The day that patients are added to transplant list, at 90 days and 1 year post transplantation	Questions about Health and Well-Being of patient after lung transplantation

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montreal, Quebec, Canada