NCT01353105

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: InCor Heart Institute · Academic / Other
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Respiratory Tract Diseases

Interventions

Type	Name	Description
PROCEDURE	Ex vivo lung transplantation	Evaluation and reconditioning of lungs following lung transplantation

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-08-01
• Completion: 2015-08-01
• First posted: 2011-05-12
• Last updated: 2011-05-12

Locations

1 site across 1 country: Brazil