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Clinical Trials/NCT01967953
NCT01967953
Completed
Phase 1

Ex-Vivo Lung Perfusion to Improve Donor Lung Function and Increase the Number of Organs Available for Transplantation

Policlinico Hospital1 site in 1 country7 target enrollmentJanuary 2011

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Disorder Related to Lung Transplantation
Sponsor
Policlinico Hospital
Enrollment
7
Locations
1
Primary Endpoint
Primary Graft Dysfunction 72 hours after lung transplantation (PGD72)
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
May 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Policlinico Hospital
Responsible Party
Principal Investigator
Principal Investigator

Franco Valenza, MD

Assistant Professor Anaesthesia and Intensive Care, Department of Pathophysiology and Transplantation, Università degli Studi di Milano

Policlinico Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Primary Graft Dysfunction 72 hours after lung transplantation (PGD72)

Time Frame: 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

Time Frame: 30 days

Secondary Outcomes

  • ICU length of stay after transplantation(30 days)
  • Duration of mechanical ventilation after transplantation(30 days)

Study Sites (1)

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