Evaluation and Reconditioning of Marginal Lung Donors to... | NCT01353105

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

NCT01353105

Sponsor

InCor Heart Institute

Status

Unknown status

Last Update Posted

May 12, 2011Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

Respiratory Tract Diseases

Interventions

Ex vivo lung transplantation

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Aug 2013Estimated

Completion Date

Aug 2015Estimated

First Submitted Date

May 11, 2011

First Submission Date that Met QC Criteria

May 11, 2011

First Posted Date

May 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2011

Last Update Posted Date

May 12, 2011Estimated

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ex vivo lung transplantation	Experimental	single-group studies	Procedure: Ex vivo lung transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ex vivo lung transplantation	Procedure	Evaluation and reconditioning of lungs following lung transplantation	Ex vivo lung transplantation

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fabio B Jatene, PhD	Contact	+55-11-3069-5197		fabiojatene@incor.usp.br
Paulo M Pego-Fernandes, PhD	Contact	+55-11-3069-5922		paulopego@incor.usp.br

Overall Officials

Name	Affiliation	Role
Fabio B Jatene, PhD	InCor Heart Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INCOR - Heart Institute		São Paulo	São Paulo	05403-000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D012140	Respiratory Tract Diseases
D003550	Cystic Fibrosis
D029424	Pulmonary Disease, Chronic Obstructive
D011658	Pulmonary Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D030342	Genetic Diseases, Inborn

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Browse Branches

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