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

May 11, 2011 updated by: InCor Heart Institute
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403-000
        • INCOR - Heart Institute
        • Contact:
        • Principal Investigator:
          • Fabio B Jatene, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 30 days after ex vivo lung transplantation
30 days after ex vivo lung transplantation
Respiratory complications (primary graft dysfunction, infection, rejection, bronchiolitis obliterates syndrome)
Time Frame: 30 days after the ex vivo lung transplantation
30 days after the ex vivo lung transplantation
12-months survival
Time Frame: 12 months survival after ex vivo lung transplantation
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
Time Frame: 72 hours after ex vivo lung transplantation
72 hours after ex vivo lung transplantation
Mechanical ventilation time
Time Frame: 30 days after ex vivo lung transplantation
30 days after ex vivo lung transplantation
Hospital and ICU time of stay
Time Frame: 12 months after ex vivo lung transplantation
12 months after ex vivo lung transplantation
Non-respiratory complications (arrhythmia, renal failure, sepsis)
Time Frame: 30 days after ex vivo lung transplantation
30 days after ex vivo lung transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCOR-1232-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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