Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| San Gerardo Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The procurement of organs from donors after cardiocirculatory death (DCD) is an accepted strategy to increase organ supply.
Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving lungs procured from donors after cardiocirculatory death reconditioned and assessed by EVLP, with that of subjects receiving lungs procured from brain death donors.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Group | No Intervention | Recipients of lungs procured from brain dead donors. | |
| EVLP-DCD Group | Active Comparator | Recipients of lungs procured from DCD donors, reconditioned/evaluated by EVLP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVLP-DCD Group | Procedure | Events: application of an open lung protective ventilatory strategy (recruitment manoeuvre, low volume-low frequency ventilation-high PEEP) to the DCD donors; procurement of lungs and cold storage on ice; reconditioning/evaluation by EVLP to assess suitability for transplantation; cold storage on ice; transplantation. Endpoints of suitability: oxygenation, respiratory mechanics, pulmonary vascular resistance, chest X-ray, fibrobronchoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| 30 Day Mortality and Graft Survival | 30 day mortality and graft survival is used as a standard research measure to evaluate post transplant outcome | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of mechanical ventilation after transplantation | 30 days | |
| ICU length of stay after transplantation | 30 days | |
| Primary Graft Dysfunction 72 hours After Transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchiolitis Obliterans Syndrome (BOS) | 12 months |
Lung donors:
Recipients:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Franco Valenza, MD | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS a' Granda - Ospedale Maggiore Policlinico | Recruiting | Milan | Milan | 20122 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Primary Graft Dysfunction 72 hours after transplantation definition: grade 3 according to the International Society of Heart and Lung Transplantation classification |
| 72 hours |