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Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion

Respiratory Tract Diseases Clinical Trial

Official title:
Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion

Clinical Trial Summary

Only about 15% of the potential candidates for lung donation are considered suitable for transplantation. A new method for ex vivo lung perfusion (EVLP) has been developed and can be used for evaluation and reconditioning of "marginal" and unacceptable lungs. The ´purpose of this study is to analyse the executability and safety of ex vivo lung perfusion pulmonary ex vivo in marginal donors.

Clinical Trial Description

Donor Inclusion criteria:

- Age < 55 years-old;

- Smoking history < 20 pack-year;

- Clear chest radiograph;

- Absence of significant chest trauma;

- Absence of purulent secretions and gastric contents at bronchoscopy;

- PaO2 < 300 mm Hg (FIO2 1.0, PEEP 5 cmH2O)

Exclusion criteria:

- Lungs presenting PO2 < 400 mmHg after ex vivo lung perfusion ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01353105
Study type Interventional
Source InCor Heart Institute
Contact Fabio B Jatene, PhD
Phone +55-11-3069-5197
Email fabiojatene@incor.usp.br
Status Not yet recruiting
Phase Phase 4
Start date August 2011
Completion date August 2015
View Details
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