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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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

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Respiratory Tract Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ex vivo lung transplantation

single-group studies

Group Type EXPERIMENTAL

Ex vivo lung transplantation

Intervention Type PROCEDURE

Evaluation and reconditioning of lungs following lung transplantation

Interventions

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Ex vivo lung transplantation

Evaluation and reconditioning of lungs following lung transplantation

Intervention Type PROCEDURE

Other Intervention Names

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Non applicable

Eligibility Criteria

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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)