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.
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
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
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.
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
RECRUITINGMeasure 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
Time frame: 12 months after transplantation
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
Time frame: 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
Time frame: Expected average of 6 weeks
Duration of mechanical ventilation
How long it takes to disconnect the patient from mechanical ventilation
Time frame: 30 days after lung transplant
Quality of life (QoL) questionnaire
Questions about Health and Well-Being of patient after lung transplantation
Time frame: 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
Time frame: 90 days after lung transplant
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