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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D005355', 'term': 'Fibrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-11', 'studyFirstSubmitDate': '2011-05-11', 'studyFirstSubmitQcDate': '2011-05-11', 'lastUpdatePostDateStruct': {'date': '2011-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-days mortality', 'timeFrame': '30 days after ex vivo lung transplantation'}, {'measure': 'Respiratory complications (primary graft dysfunction, infection, rejection, bronchiolitis obliterates syndrome)', 'timeFrame': '30 days after the ex vivo lung transplantation'}, {'measure': '12-months survival', 'timeFrame': '12 months survival after ex vivo lung transplantation'}], 'secondaryOutcomes': [{'measure': 'Oxygenation index (PaO2/FiO2)on ICU arrival and 72 hours', 'timeFrame': '72 hours after ex vivo lung transplantation'}, {'measure': 'Mechanical ventilation time', 'timeFrame': '30 days after ex vivo lung transplantation'}, {'measure': 'Hospital and ICU time of stay', 'timeFrame': '12 months after ex vivo lung transplantation'}, {'measure': 'Non-respiratory complications (arrhythmia, renal failure, sepsis)', 'timeFrame': '30 days after ex vivo lung transplantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cystic fibrosis', 'chronic obstructive pulmonary disease', 'pulmonary fibrosis'], 'conditions': ['Respiratory Tract Diseases']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Donor Inclusion criteria:\n\n* Age \\< 55 years-old;\n* Smoking history \\< 20 pack-year;\n* Clear chest radiograph;\n* Absence of significant chest trauma;\n* Absence of purulent secretions and gastric contents at bronchoscopy;\n* PaO2 \\< 300 mm Hg (FIO2 1.0, PEEP 5 cmH2O)\n\nExclusion criteria:\n\n* Lungs presenting PO2 \\< 400 mmHg after ex vivo lung perfusion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\< 55 years-old;\n* Smoking history \\< 20 pack-year;\n* Clear chest radiograph;\n* Absence of significant chest trauma;\n* Absence of purulent secretions and gastric contents at bronchoscopy;\n* PaO2 \\< 300 mm Hg (FIO2 1.0, PEEP 5 cmH2O)\n\nExclusion Criteria:\n\n* Lungs presenting PO2 \\< 400 mmHg after ex vivo lung perfusion'}, 'identificationModule': {'nctId': 'NCT01353105', 'briefTitle': 'Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion', 'organization': {'class': 'OTHER', 'fullName': 'InCor Heart Institute'}, 'officialTitle': 'Evaluation and Reconditioning of Marginal Lung Donors to Transplantation by ex Vivo Lung Perfusion', 'orgStudyIdInfo': {'id': 'INCOR-1232-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ex vivo lung transplantation', 'description': 'single-group studies', 'interventionNames': ['Procedure: Ex vivo lung transplantation']}], 'interventions': [{'name': 'Ex vivo lung transplantation', 'type': 'PROCEDURE', 'otherNames': ['Non applicable'], 'description': 'Evaluation and reconditioning of lungs following lung transplantation', 'armGroupLabels': ['Ex vivo lung transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Fabio B Jatene, PhD', 'role': 'CONTACT', 'email': 'fabiojatene@incor.usp.br', 'phone': '+55-11-30695197'}, {'name': 'Fabio B Jatene, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'INCOR - Heart Institute', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Fabio B Jatene, PhD', 'role': 'CONTACT', 'email': 'fabiojatene@incor.usp.br', 'phone': '+55-11-3069-5197'}, {'name': 'Paulo M Pego-Fernandes, PhD', 'role': 'CONTACT', 'email': 'paulopego@incor.usp.br', 'phone': '+55-11-3069-5922'}], 'overallOfficials': [{'name': 'Fabio B Jatene, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'InCor Heart Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InCor Heart Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Fabio Biscegli Jatene/ Full Professor of Thoracic Surgery - Medical School, University of São Paulo', 'oldOrganization': 'InCor Heart Institute'}}}}