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

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Tract Diseases
• Intervention / Treatment: Procedure: Ex vivo lung transplantation

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403-000
      • INCOR - Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ex vivo lung transplantation; single-group studies	Procedure: Ex vivo lung transplantation; Evaluation and reconditioning of lungs following lung transplantation; Other Names: Non applicable

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: InCor Heart Institute
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Fabio B Jatene, PhD, InCor Heart Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: May 11, 2011
• First Submitted That Met QC Criteria: May 11, 2011
• First Posted (Estimate): May 12, 2011

Study Record Updates

• Last Update Posted (Estimate): May 12, 2011
• Last Update Submitted That Met QC Criteria: May 11, 2011
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: cystic fibrosis; chronic obstructive pulmonary disease; pulmonary fibrosis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases
• Other Study ID Numbers: INCOR-1232-09