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

Phase 4

• Conditions: Respiratory Tract Diseases
• Interventions: Procedure: Ex vivo lung transplantation

• Registration Number: NCT01353105
• Lead Sponsor: InCor Heart Institute

Brief 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

Study Timeline

• Status Verified: 2010-10
• Study First Submitted: 2011-05-11
• Study First Submitted QC: 2011-05-11
• Last Update Submitted: 2011-05-11
• Study First Posted: 2011-05-12
• Last Update Posted: 2011-05-12
• Study Start: 2011-08
• Primary Completion: 2013-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ex vivo lung transplantation	Ex vivo lung transplantation	single-group studies

Primary Outcome Measures

Name	Time	Method
12-months survival	12 months survival after ex vivo lung transplantation
Respiratory complications (primary graft dysfunction, infection, rejection, bronchiolitis obliterates syndrome)	30 days after the ex vivo lung transplantation
30-days mortality	30 days after ex vivo lung transplantation

Secondary Outcome Measures

Name	Time	Method
Non-respiratory complications (arrhythmia, renal failure, sepsis)	30 days after ex vivo lung transplantation
Oxygenation index (PaO2/FiO2)on ICU arrival and 72 hours	72 hours after ex vivo lung transplantation
Hospital and ICU time of stay	12 months after ex vivo lung transplantation
Mechanical ventilation time	30 days after ex vivo lung transplantation

Trial Locations

Locations (1)

INCOR - Heart Institute; 🇧🇷 São Paulo, SP, Brazil