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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01353105
• Other study ID #: INCOR-1232-09
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 11, 2011
• Last updated: May 11, 2011
• Start date: August 2011
• Est. completion date: August 2015

Study information

• Verified date: October 2010
• Source: InCor Heart Institute
• Contact: Fabio B Jatene, PhD
• Phone: +55-11-3069-5197
• Email: fabiojatene[@]incor.usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2015
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 70 Years

Eligibility

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

• Respiratory Tract Diseases

Intervention

Procedure:
• Ex vivo lung transplantation
Evaluation and reconditioning of lungs following lung transplantation

Locations

Country	Name	City	State
Brazil	INCOR - Heart Institute	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
InCor Heart Institute	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-days mortality		30 days after ex vivo lung transplantation	Yes
Primary	Respiratory complications (primary graft dysfunction, infection, rejection, bronchiolitis obliterates syndrome)		30 days after the ex vivo lung transplantation	Yes
Primary	12-months survival		12 months survival after ex vivo lung transplantation	Yes
Secondary	Oxygenation index (PaO2/FiO2)on ICU arrival and 72 hours		72 hours after ex vivo lung transplantation	No
Secondary	Mechanical ventilation time		30 days after ex vivo lung transplantation	No
Secondary	Hospital and ICU time of stay		12 months after ex vivo lung transplantation	No
Secondary	Non-respiratory complications (arrhythmia, renal failure, sepsis)		30 days after ex vivo lung transplantation	No