Recruitment

Recruitment Status
Completed

Inclusion Criterias

Recipient to undergo single or bilateral Lung Transplantation
Donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) below 300 mmHg, or doubtful donor lung function
Recipient to undergo single or bilateral Lung Transplantation
Donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) below 300 mmHg, or doubtful donor lung function

Exclusion Criterias

Aspiration
Pneumonia
Massive lung contusion
...
Aspiration
Pneumonia
Massive lung contusion
Sepsis
Malignancy

Summary

Conditions
  • Brain Death
  • Disorder Related to Lung Transplantation
  • Graft Failure
  • Primary Graft Dysfunction
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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.

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.

Inclusion Criterias

Recipient to undergo single or bilateral Lung Transplantation
Donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) below 300 mmHg, or doubtful donor lung function
Recipient to undergo single or bilateral Lung Transplantation
Donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) below 300 mmHg, or doubtful donor lung function

Exclusion Criterias

Aspiration
Pneumonia
Massive lung contusion
...
Aspiration
Pneumonia
Massive lung contusion
Sepsis
Malignancy

Locations

Milan, 20122
Milan, 20122

Tracking Information

NCT #
NCT01967953
Collaborators
Not Provided
Investigators
  • Principal Investigator: Franco Valenza, MD Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico Milan Italy
  • Franco Valenza, MD Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico Milan Italy