Brain Death, Disorder Related to Lung Transplantation, Graft Failure, Primary Graft Dysfunction
Conditions
Brief summary
The recent introduction of ex-vivo lung perfusion (EVLP) as a tool to evaluate and recondition lungs from marginal donors has opened a new era in the field of lung transplantation.
Detailed description
Aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving marginal lungs procured from brain death donors and reconditioned by EVLP, with that of subjects receiving lungs procured from standard donors.
Interventions
PROCEDUREEVLP Group
EVLP technique: Steen solution; normothermia; low flow, open atrium, low hematocrit. Endpoints of EVLP assessment of lungs suitability: oxygenation, respiratory mechanics, pulmonary vascular resistance, chest X-ray, fibrobronchoscopy
Sponsors
Policlinico Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for donor lung: 1. Recipient to undergo single or bilateral Lung Transplantation 2. Donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) below 300 mmHg, or doubtful donor lung function
Exclusion criteria
for donor lung: 1. Massive lung contusion 2. Aspiration 3. Pneumonia 4. Sepsis 5. Malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Graft Dysfunction 72 hours after lung transplantation (PGD72) | 72 hours | Primary Graft Dysfunction 72 hours after transplantation (PGD72) definition: grade 3 according to the International Society of Heart and Lung Transplantation classification |
| 30 day Mortality | 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of mechanical ventilation after transplantation | 30 days |
| ICU length of stay after transplantation | 30 days |
Countries
Italy
Outcome results
None listed