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

Primary Purpose

Respiratory Tract Diseases

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Ex vivo lung transplantation
Sponsored by
InCor Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Tract Diseases focused on measuring cystic fibrosis, chronic obstructive pulmonary disease, pulmonary fibrosis

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • INCOR - Heart Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ex vivo lung transplantation

Arm Description

single-group studies

Outcomes

Primary Outcome Measures

30-days mortality
Respiratory complications (primary graft dysfunction, infection, rejection, bronchiolitis obliterates syndrome)
12-months survival

Secondary Outcome Measures

Oxygenation index (PaO2/FiO2)on ICU arrival and 72 hours
Mechanical ventilation time
Hospital and ICU time of stay
Non-respiratory complications (arrhythmia, renal failure, sepsis)

Full Information

First Posted
May 11, 2011
Last Updated
May 11, 2011
Sponsor
InCor Heart Institute
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01353105
Brief Title
Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion
Official Title
Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
InCor Heart Institute
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Diseases
Keywords
cystic fibrosis, chronic obstructive pulmonary disease, pulmonary fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ex vivo lung transplantation
Arm Type
Experimental
Arm Description
single-group studies
Intervention Type
Procedure
Intervention Name(s)
Ex vivo lung transplantation
Other Intervention Name(s)
Non applicable
Intervention Description
Evaluation and reconditioning of lungs following lung transplantation
Primary Outcome Measure Information:
Title
30-days mortality
Time Frame
30 days after ex vivo lung transplantation
Title
Respiratory complications (primary graft dysfunction, infection, rejection, bronchiolitis obliterates syndrome)
Time Frame
30 days after the ex vivo lung transplantation
Title
12-months survival
Time Frame
12 months survival after ex vivo lung transplantation
Secondary Outcome Measure Information:
Title
Oxygenation index (PaO2/FiO2)on ICU arrival and 72 hours
Time Frame
72 hours after ex vivo lung transplantation
Title
Mechanical ventilation time
Time Frame
30 days after ex vivo lung transplantation
Title
Hospital and ICU time of stay
Time Frame
12 months after ex vivo lung transplantation
Title
Non-respiratory complications (arrhythmia, renal failure, sepsis)
Time Frame
30 days after ex vivo lung transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabio B Jatene, PhD
Phone
+55-11-3069-5197
Email
fabiojatene@incor.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Paulo M Pego-Fernandes, PhD
Phone
+55-11-3069-5922
Email
paulopego@incor.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio B Jatene, PhD
Organizational Affiliation
InCor Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
INCOR - Heart Institute
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio B Jatene, PhD
Phone
+55-11-30695197
Email
fabiojatene@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Fabio B Jatene, PhD

12. IPD Sharing Statement

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

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