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| Name | Class |
|---|---|
| Fondation Pour La Recherche en Chirurgie Thoracique De Montreal | UNKNOWN |
| Centre de Recherche du Centre Hospitalier de l'Université de Montréal | OTHER |
| Institut de Recherches Cliniques de Montreal | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers | Measure the concentrations of calgranulin and high mobility group box-1 (HMGB1) | 1 hour pre- and up to 30 days post-transplant |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Menaouar, PhD | Contact | 514-890-8000 | 30785 | ahmed.menaouar.chum@ssss.gouv.qc.ca |
| Basil Nasir, MD | Contact | 514-890-8000 | 26275 | basilsnair@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pasquale Ferraro, MD | CHUM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal (CHUM) | Recruiting | Montreal | Quebec | H2X 3E4 | Canada |
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| 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 |
| Duration of mechanical ventilation | How long it takes to disconnect the patient from mechanical ventilation | 30 days after lung transplant |
| 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 |
| 90 day Mortality | Patient survival 90 days after lung transplantation | 90 days after lung transplant |