Lung Transplant
Conditions
Keywords
Lung Transplantation, Ex Vivo Lung Perfusion, EVLP
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.
Interventions
PROCEDUREEVLP 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.
Sponsors
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)
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers | 1 hour pre- and up to 30 days post-transplant | Measure the concentrations of calgranulin and high mobility group box-1 (HMGB1) |
Countries
Canada
Contacts
Primary ContactAhmed Menaouar, PhD
Backup ContactBasil Nasir, MD
Outcome results
None listed