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

This study is not yet open for participant recruitment.
Verified October 2010 by InCor Heart Institute
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
InCor Heart Institute
ClinicalTrials.gov Identifier:
NCT01353105
First received: May 11, 2011
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Respiratory Tract Diseases
 Procedure: Ex vivo lung transplantation
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by InCor Heart Institute:

Primary Outcome Measures:
  • 30-days mortality [ Time Frame: 30 days after ex vivo lung transplantation ] [ Designated as safety issue: Yes ]
  • Respiratory complications (primary graft dysfunction, infection, rejection, bronchiolitis obliterates syndrome) [ Time Frame: 30 days after the ex vivo lung transplantation ] [ Designated as safety issue: Yes ]
  • 12-months survival [ Time Frame: 12 months survival after ex vivo lung transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Oxygenation index (PaO2/FiO2)on ICU arrival and 72 hours [ Time Frame: 72 hours after ex vivo lung transplantation ] [ Designated as safety issue: No ]
  • Mechanical ventilation time [ Time Frame: 30 days after ex vivo lung transplantation ] [ Designated as safety issue: No ]
  • Hospital and ICU time of stay [ Time Frame: 12 months after ex vivo lung transplantation ] [ Designated as safety issue: No ]
  • Non-respiratory complications (arrhythmia, renal failure, sepsis) [ Time Frame: 30 days after ex vivo lung transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ex vivo lung transplantation
single-group studies
 Procedure: Ex vivo lung transplantation
Evaluation and reconditioning of lungs following lung transplantation
Other Name: Non applicable

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
  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353105

Contacts
Contact: Fabio B Jatene, PhD +55-11-3069-5197 fabiojatene@incor.usp.br
Contact: Paulo M Pego-Fernandes, PhD +55-11-3069-5922 paulopego@incor.usp.br

Locations
Brazil
INCOR - Heart Institute Not yet recruiting
São Paulo, SP, Brazil, 05403-000
Contact: Fabio B Jatene, PhD     +55-11-30695197     fabiojatene@incor.usp.br    
Principal Investigator: Fabio B Jatene, PhD            
Sponsors and Collaborators
InCor Heart Institute
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Fabio B Jatene, PhD InCor Heart Institute
  More Information

No publications provided

Responsible Party: Fabio Biscegli Jatene/ Full Professor of Thoracic Surgery - Medical School, University of São Paulo, InCor Heart Institute
ClinicalTrials.gov Identifier: NCT01353105     History of Changes
Other Study ID Numbers: INCOR-1232-09
Study First Received: May 11, 2011
Last Updated: May 11, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by InCor Heart Institute:
cystic fibrosis
chronic obstructive pulmonary disease
pulmonary fibrosis

Additional relevant MeSH terms:
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013