Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT01353105
Status:
UNKNOWN
Last Update Posted:
2011-05-12
First Post:
2011-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion
Sponsor:
InCor Heart Institute
Organization:
Study Overview
Official Title:
Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion
Status:
UNKNOWN
Status Verified Date:
2010-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: