Respiratory Tract DiseasesPhase 4NCT01353105
Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion
A Phase 4 study testing Ex vivo lung transplantation in people with Respiratory Tract Diseases, run by InCor Heart Institute at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Respiratory Tract Diseases
- What is being tested?
- Ex vivo lung transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Aug 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Lungs presenting PO2 < 400 mmHg after ex vivo lung perfusion
Trial locations and contacts
1 site in 1 country.
Brazil1 site
INCOR - Heart Institute
São Paulo, São Paulo, 05403-000
Fabio B Jatene, PhD, +55-11-30695197, fabiojatene@incor.usp.br
Fabio B Jatene, PhD
About this study
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.
Read the 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
- Conditions
- Respiratory Tract Diseases
- Being tested
- Ex vivo lung transplantation
- Keywords
- cystic fibrosis, chronic obstructive pulmonary disease, pulmonary fibrosis
- Medical subject headings
- Respiratory Tract Diseases, Cystic Fibrosis, Pulmonary Disease, Chronic Obstructive, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex vivo lung transplantationProcedure or surgery
Also called Non applicable
Evaluation and reconditioning of lungs following lung transplantation
| Study group | Role | What they receive |
|---|---|---|
| Ex vivo lung transplantation | Experimental | single-group studies Receives: Procedure: Ex vivo lung transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-days mortality
Measured: 30 days after ex vivo lung transplantation
Respiratory complications (primary graft dysfunction, infection, rejection, bronchiolitis obliterates syndrome)
Measured: 30 days after the ex vivo lung transplantation
12-months survival
Measured: 12 months survival after ex vivo lung transplantation
Secondary outcomes (4)
Oxygenation index (PaO2/FiO2)on ICU arrival and 72 hours
Measured: 72 hours after ex vivo lung transplantation
Mechanical ventilation time
Measured: 30 days after ex vivo lung transplantation
Hospital and ICU time of stay
Measured: 12 months after ex vivo lung transplantation
Non-respiratory complications (arrhythmia, renal failure, sepsis)
Measured: 30 days after ex vivo lung transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2013 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InCor Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Fabio B Jatene, PhD, Principal investigator, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353105
- Sponsor's protocol ID
- INCOR-1232-09
- Status last verified
- Oct 2010
- First submitted
- 11 May 2011
- Last updated
- 12 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion
- ClinicalTrials.gov ID
- NCT01353105
- Acronym / sponsor ID
- INCOR-1232-09
- Conditions
- Respiratory Tract Diseases
- Keywords
- cystic fibrosis, chronic obstructive pulmonary disease, pulmonary fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- InCor Heart InstituteUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Aug 2011
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 12 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ex vivo lung transplantation | Experimental | Procedure: Ex vivo lung transplantationsingle-group studies |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- Lungs presenting PO2 < 400 mmHg after ex vivo lung perfusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ex vivo lung transplantationAlso: Non applicableEvaluation and reconditioning of lungs following lung transplantation | Procedure or surgery | Ex vivo lung transplantation |
Primary outcome
30-days mortality
Time frame: 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
12-months survival
Time frame: 12 months survival after ex vivo lung transplantation
4 secondary outcomes
Oxygenation index (PaO2/FiO2)on ICU arrival and 72 hours
Time frame: 72 hours after ex vivo lung transplantation
Mechanical ventilation time
Time frame: 30 days after ex vivo lung transplantation
Hospital and ICU time of stay
Time frame: 12 months after ex vivo lung transplantation
Non-respiratory complications (arrhythmia, renal failure, sepsis)
Time frame: 30 days after ex vivo lung transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio B Jatene, PhD principal investigator
InCor Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ex vivo lung transplantation in people with Respiratory Tract Diseases, run by InCor Heart Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabio B Jatene, PhD (+55-11-3069-5197, fabiojatene@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-days mortality (time frame: 30 days after ex vivo lung transplantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2011.