Ex-Vivo Lung Perfusion to Increase the Number of Organs for Transplantation

Phase 1

Completed

• Conditions: Disorder Related to Lung Transplantation; Brain Death; Graft Failure; Primary Graft Dysfunction

• 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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-10
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-22
• Last Update Submitted: 2013-10-22
• Study First Posted: 2013-10-23
• Last Update Posted: 2013-10-23

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

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