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

University of São Paulo (USP)

Status and phase: Unknown; Phase 4

Conditions: Respiratory Tract Diseases

Treatments: Procedure: Ex vivo lung transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01353105

INCOR-1232-09

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Ex vivo lung transplantation

Experimental group

Description:

single-group studies

Treatment:

Procedure: Ex vivo lung transplantation