Ex-Vivo Lung Perfusion to Increase the Number of Organs for Transplantation
Phase 1
Completed
- Conditions
- Disorder Related to Lung TransplantationBrain DeathGraft FailurePrimary Graft Dysfunction
- Interventions
- Procedure: EVLP Group
- Registration Number
- NCT01967953
- Lead Sponsor
- Policlinico Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EVLP Group EVLP Group Recipients of marginal lungs procured from brain death donors and reconditioned with ex-vivo lung perfusion (EVLP). Events: lung procurement, cold storage on ice, reconditioning by EVLP, cold storage on ice, transplantation.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method ICU length of stay after transplantation 30 days Duration of mechanical ventilation after transplantation 30 days
Trial Locations
- Locations (1)
Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico
🇮🇹Milan, Italy