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

NCT01353105 | Unknown Phase 4

• 1 other identifier: INCOR-1232-09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Diseases

Keywords

cystic fibrosis; chronic obstructive pulmonary disease; pulmonary fibrosis

Outcome Measures

Primary Outcomes (3)

• 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 (4)

• 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

• Hospital and ICU time of stay

  12 months after ex vivo lung transplantation

• Non-respiratory complications (arrhythmia, renal failure, sepsis)

  30 days after ex vivo lung transplantation

Study Arms (1)

Ex vivo lung transplantation

EXPERIMENTAL

single-group studies

Procedure: Ex vivo lung transplantation

Interventions

Ex vivo lung transplantation PROCEDURE

Evaluation and reconditioning of lungs following lung transplantation

Also known as: Non applicable

Ex vivo lung transplantation

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Lungs presenting PO2 \< 400 mmHg after ex vivo lung perfusion

Sponsors & Collaborators

• InCor Heart Institute: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

INCOR - Heart Institute

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Respiratory Tract Diseases; Cystic Fibrosis; Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Interstitial; Fibrosis

Study Officials

• Fabio B Jatene, PhD

  InCor Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 12, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2015
• Last Updated: May 12, 2011

Record last verified: 2010-10

Locations

BR (1)