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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01353105

Enrollment

Registered

2011-05-12

Start date

2011-08-31

Completion date

2015-08-31

Last updated

2011-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Tract Diseases

Keywords

cystic fibrosis, chronic obstructive pulmonary disease, pulmonary fibrosis

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

Interventions

PROCEDUREEx vivo lung transplantation

Evaluation and reconditioning of lungs following lung transplantation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 70 Years

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Oxygenation index (PaO2/FiO2)on ICU arrival and 72 hours	72 hours after ex vivo lung transplantation
Non-respiratory complications (arrhythmia, renal failure, sepsis)	30 days 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

Countries

Brazil

Contacts

Primary ContactFabio B Jatene, PhD

fabiojatene@incor.usp.br+55-11-3069-5197

Backup ContactPaulo M Pego-Fernandes, PhD

paulopego@incor.usp.br+55-11-3069-5922

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026