Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT06086405
Status:
UNKNOWN
Last Update Posted:
2023-10-17
First Post:
2023-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ECMO Braile Biomédica® in COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-13', 'studyFirstSubmitDate': '2023-10-13', 'studyFirstSubmitQcDate': '2023-10-13', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effectiveness of the oxygenator in ensuring adequate gas exchange', 'timeFrame': 'during the first week of use', 'description': 'To ensure adequate oxygenation (post-membrane pO2 \\> 150 mmHg during the first week of use) and CO2 elimination (post-membrane pCO2 \\< 40 mmHg or pre-membrane pCO2 - post-membrane pCO2 \\> 10 mmHg)'}, {'measure': 'The effectiveness of the set in ensuring adequate flow to the patient', 'timeFrame': 'during the use of extracorporeal membrane oxygenation', 'description': 'Nominal flow calculated according to weight or body surface area (50 to 80 mL/Kg or 2.4 L/min of body surface area'}], 'secondaryOutcomes': [{'measure': 'Rate free of membrane dysfunction', 'timeFrame': 'during the use of extracorporeal membrane oxygenation', 'description': 'percentage of oxygenators free from dysfunction'}, {'measure': 'Need for oxygenator due to dysfunction', 'timeFrame': 'during the use of extracorporeal membrane oxygenation', 'description': 'percentage of oxygenators that needed to be replaced due to dysfunction'}, {'measure': 'Decannulation rate', 'timeFrame': 'during the use of extracorporeal membrane oxygenation', 'description': 'percentage of patients who were decannulated from ECMO'}, {'measure': 'Mortality rate during ECMO use', 'timeFrame': 'during the use of extracorporeal membrane oxygenation', 'description': 'percentage of patients who progressed to mortality during ECMO use'}, {'measure': 'Duration of ECMO system usage', 'timeFrame': 'during the use of extracorporeal membrane oxygenation', 'description': 'Total duration of ECMO use (in days)'}, {'measure': 'Adverse events during extracorporeal membrane oxygenation use', 'timeFrame': 'during the use of extracorporeal membrane oxygenation', 'description': 'percentage of adverse events related to the oxygenator'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ECMO', 'COVID-19', 'Membrane Oxygenator'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Retrospective data collection to evaluate the gas transfer capacity of the Braile Biomédica® OxyPrime® ECMO BRCoating® Membrane Oxygenator in COVID-19 patients during the pandemic.', 'detailedDescription': 'Multicenter, retrospective, non-comparative, non-randomized study to assess the clinical performance of the OxyPrime® ECMO BRCoating® Membrane Oxygenator in adult patients with COVID-19'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ≥ 18 years old, with a previous diagnosis of COVID-19, who were placed on ECMO using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years old, with a previous diagnosis of COVID-19, who were placed on ECMO using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator, from March 2020 to July 2022, following the Instructions for Use (IFU) of the products.\n\nExclusion Criteria:\n\n* Patients without a diagnosis of COVID-19'}, 'identificationModule': {'nctId': 'NCT06086405', 'acronym': 'ECMO_COVID', 'briefTitle': 'ECMO Braile Biomédica® in COVID-19 Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Braile Biomedica Ind. Com. e Repr. Ltda.'}, 'officialTitle': 'ECMO Braile Biomédica® in COVID-19 Patients Post-market Clinical Trial to Verify the Performance of the ECMO System', 'orgStudyIdInfo': {'id': 'ECMO COVID'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Patients underwent cardiorespiratory support', 'type': 'DEVICE', 'description': 'Patients underwent cardiorespiratory support using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71681-603', 'city': 'Lago Sul', 'state': 'Brasília - DF', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Vitor S Barzilai', 'role': 'CONTACT', 'email': 'vitorbarzilai@ictdf.org.br', 'phone': '+55 (61) 3305 8208', 'phoneExt': '8209'}], 'facility': 'Hospital Brasília', 'geoPoint': {'lat': -15.84577, 'lon': -47.88369}}], 'centralContacts': [{'name': 'Glacia G Basso', 'role': 'CONTACT', 'email': 'glaucia.basso@braile.com.br', 'phone': '+55(17)2136-7005'}, {'name': 'Priscila C Joao', 'role': 'CONTACT', 'email': 'priscila.joao@braile.com.br', 'phone': '+55(17)2136-7005'}], 'overallOfficials': [{'name': 'Vitor S Barzila', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Brasília'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Braile Biomedica Ind. Com. e Repr. Ltda.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}