EVLP to Evaluate the Eligibility for Transplantation of DCD-Lungs

Phase 1

• Conditions: Disorders Related to Lung Transplantation; Graft Failure

• Registration Number: NCT02061462
• Lead Sponsor: Policlinico Hospital

Brief Summary

The procurement of organs from donors after cardiocirculatory death (DCD) is an accepted strategy to increase organ supply.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-12
• Study Start: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-25
• Last Update Posted: 2014-11-26
• Primary Completion: 2016-10
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
30 Day Mortality and Graft Survival	30 days	30 day mortality and graft survival is used as a standard research measure to evaluate post transplant outcome

Secondary Outcome Measures

Name	Time	Method
ICU length of stay after transplantation	30 days
Primary Graft Dysfunction 72 hours After Transplantation	72 hours	Primary Graft Dysfunction 72 hours after transplantation definition: grade 3 according to the International Society of Heart and Lung Transplantation classification
Duration of mechanical ventilation after transplantation	30 days

Trial Locations

Locations (1)

Fondazione IRCCS a' Granda - Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy