Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT03179020
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2017-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Donation Network to Optimize Organ Recovery Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001926', 'term': 'Brain Death'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003128', 'term': 'Coma'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In the present study ICUs will be randomized to manage potential organ donors through the use of a evidence-based checklist or to manage potential organ donors according usual care.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1535}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-30', 'studyFirstSubmitDate': '2017-03-23', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Losses of potential donors due to cardiac arrest', 'timeFrame': 'This event will be evaluated from the date of study subject enrollment until the date of organ recovery or end of brain death protocol (for cases of family refusal or contraindications to organ recovery) assessed up to 14 days', 'description': 'Proportion of losses of potential donors due to cardiac arrest'}], 'secondaryOutcomes': [{'measure': 'Effective organ donor', 'timeFrame': 'This event will be evaluated from the date of study subject enrollment until the date of organ recovery or end of brain death protocol (for cases of family refusal or contraindications to organ recovery) assessed up to 14 days', 'description': 'Proportion of Effective organ donors'}, {'measure': 'Organ recovery per effective donor', 'timeFrame': 'This event will be evaluated from the date of study subject enrollment until the date of organ recovery assessed up to 14 days', 'description': 'Number of organs recovery per effective donor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive Care Units', 'Brain Death', 'Organ Donation', 'Family interview'], 'conditions': ['Brain Death', 'Organ Donation']}, 'referencesModule': {'references': [{'pmid': '38095899', 'type': 'DERIVED', 'citation': 'Westphal GA, Robinson CC, Giordani NE, Teixeira C, Rohden AI, Dos Passos Gimenes B, Guterres CM, Madalena IC, Andrighetto LV, Souza da Silva S, Barbosa da Silva D, Sganzerla D, Cavalcanti AB, Franke CA, Bozza FA, Machado FR, de Andrade J, Pontes Azevedo LC, Schneider S, Orlando BR, Grion CMC, Bezerra FA, Roman FR, Leite FO Jr, Ferraz Siqueira IL, Oliveira JFP, de Oliveira LC Jr, de Melo MFRB, Leal PBGP, Diniz PC, Moraes RB, Salomao Pontes DF, Araujo Queiroz JE, Hammes LS, Meade MO, Rosa RG, Falavigna M; DONORS (Donation Network to Optimize Organ Recovery Study) Investigators and the BRICNet (Brazilian Research in Intensive Care Network). Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors: The DONORS Cluster Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2346901. doi: 10.1001/jamanetworkopen.2023.46901.'}, {'pmid': '32552839', 'type': 'DERIVED', 'citation': 'Giordani NE, Robinson CC, Westphal GA, Rosa RG, Sganzerla D, Cavalcanti AB, Machado FR, Azevedo LCP, Bozza FA, Teixeira C, de Andrade J, Franke CA, Guterres CM, Madalena IC, Rohden AI, da Silva SS, Andrighetto LV, Rech GS, Gimenes BDP, Hammes LS, Pontes DFS, Meade MO, Falavigna M. Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study). Trials. 2020 Jun 17;21(1):540. doi: 10.1186/s13063-020-04457-1.'}, {'pmid': '31243035', 'type': 'DERIVED', 'citation': 'Westphal GA, Robinson CC, Biasi A, Machado FR, Rosa RG, Teixeira C, de Andrade J, Franke CA, Azevedo LCP, Bozza F, Guterres CM, da Silva DB, Sganzerla D, do Prado DZ, Madalena IC, Rohden AI, da Silva SS, Giordani NE, Andrighetto LV, Benck PS, Roman FR, de Melo MFRB, Pereira TB, Grion CMC, Diniz PC, Oliveira JFP, Mecatti GC, Alves FAC, Moraes RB, Nobre V, Hammes LS, Meade MO, Nothen RR, Falavigna M; DONORS (Donation Network to Optimise Organ Recovery Study) Investigators and the BRICNet. DONORS (Donation Network to Optimise Organ Recovery Study): Study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial. BMJ Open. 2019 Jun 25;9(6):e028570. doi: 10.1136/bmjopen-2018-028570.'}]}, 'descriptionModule': {'briefSummary': 'This study consists in an cluster-randomized clinical trial involving near 60 Brazilian intensive care units (ICUs) with a high notification rate of potential donors of organs and tissues. ICUs will be randomized in a 1:1 ratio to manage potential organ donors through the use of a evidence-based checklist or to manage potential organ donors according usual care. The primary outcome is the rate of losses of potential donors due to cardiac arrest. Secondary outcome measures include number of effective organ donors and number of organs recovery per effective donor. The first subject was enrolled on June 20, 2018.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor ICUs:\n\n* Adults ICUs reporting at least 10 potential valid donors (without clinical contraindications for donation) per year\n\nFor potential donor:\n\n* Age of 14 years or older\n* Suspected brain death after the first clinical test\n\nExclusion Criteria:\n\nFor ICUs:\n\n* Coronary units, intermediate units, emergency services\n* ICUs that use checklist for the management of the potential donors\n\nFor potential donors:\n\n* Age \\>90 years\n* HIV\n* Metastatic cancer\n* Uncontrolled sepsis\n* Acute hepatitis\n* Malaria\n* Acute viral infections\n* Cryptococcal meningoencephalitis and prion diseases\n* Active tuberculosis treated less than 2 months\n* Colonization of the donor by bacteria without any option of antibiotic treatment\n* History of breast tumor, melanoma, soft tissue sarcoma or hematologic neoplasia, WHO Group 3 primary tumors'}, 'identificationModule': {'nctId': 'NCT03179020', 'acronym': 'DONORS', 'briefTitle': 'Donation Network to Optimize Organ Recovery Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Moinhos de Vento'}, 'officialTitle': 'Cluster Randomized Trial Evaluating the Implementation of a Evidence Based Checklist for the Management of Potential Organ Donors', 'orgStudyIdInfo': {'id': 'DONORS Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Checklist ICUs', 'description': 'Management of the potential donor guided by the use of an evidence-based checklist. This checklist is based on main recommendations of the Brazilian guideline for the management of potential multiple organ donors.', 'interventionNames': ['Other: Checklist use']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care ICUs', 'description': 'Management of the potential donor according usual care.', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'Checklist use', 'type': 'OTHER', 'description': 'Management of the potential donor guided by the use of an evidence-based checklist. This checklist is based on main recommendations of the Brazilian guideline for the management of potential multiple organ donors.', 'armGroupLabels': ['Checklist ICUs']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'Management of the potential donor according usual care.', 'armGroupLabels': ['Usual Care ICUs']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rio Branco', 'state': 'Acre', 'country': 'Brazil', 'facility': 'Hospital das Clínicas de Rio Branco', 'geoPoint': {'lat': -9.97472, 'lon': -67.81}}, {'city': 'Rio Branco', 'state': 'Acre', 'country': 'Brazil', 'facility': 'Hospital de Urgência e Emergência de Rio Branco', 'geoPoint': {'lat': -9.97472, 'lon': -67.81}}, {'city': 'Maceió', 'state': 'Alagoas', 'country': 'Brazil', 'facility': 'Hospital Geral Prof. Osvaldo Brandão Vilela', 'geoPoint': {'lat': -9.66583, 'lon': -35.73528}}, {'city': 'Manaus', 'state': 'Amazonas', 'country': 'Brazil', 'facility': 'Hospital de Pronto Socorro Dr. João Lúcio Pereira Machado', 'geoPoint': {'lat': -3.10194, 'lon': -60.025}}, {'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Hospital Geral de Fortaleza', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Hospital Insituto Dr José Frota', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'city': 'Juazeiro do Norte', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Hospital Regional do Cariri', 'geoPoint': {'lat': -7.21306, 'lon': -39.31528}}, {'city': 'Mossoró', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Hospital Regional Tarcisio de Vasconcelos Maia'}, {'city': 'Sobral', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Hospital Regional Norte', 'geoPoint': {'lat': -3.68611, 'lon': -40.34972}}, {'city': 'Sobral', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Santa Casa de Misericórdia de Sobral', 'geoPoint': {'lat': -3.68611, 'lon': -40.34972}}, {'city': 'Vitória', 'state': 'Espírito Santo', 'country': 'Brazil', 'facility': 'Hospital Estadual de Urgência e Emergência de Vitória', 'geoPoint': {'lat': -20.31944, 'lon': -40.33778}}, {'city': 'Feira de Santana', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital Geral Cleriston Andrade', 'geoPoint': {'lat': -12.26667, 'lon': -38.96667}}, {'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Hospital de Base do Distrito Federal', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Hospital de Urgência de Goiânia', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'city': 'São Luís', 'state': 'Maranhão', 'country': 'Brazil', 'facility': 'Hospital Dr Carlos Macieira', 'geoPoint': {'lat': -2.52972, 'lon': -44.30278}}, {'city': 'São Luís', 'state': 'Maranhão', 'country': 'Brazil', 'facility': 'Socorrão I - Hospital Municipal Djalma Marques', 'geoPoint': {'lat': -2.52972, 'lon': -44.30278}}, {'city': 'Campo Grande', 'state': 'Mato Grosso do Sul', 'country': 'Brazil', 'facility': 'Santa Casa de Campo Grande', 'geoPoint': {'lat': -20.44278, 'lon': -54.64639}}, {'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital das Clinicas das Minas Gerais', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital João XXIII Fundação Hospitalar do Estado de Minas Gerais', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital Universitário Ciências Médicas', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Santa Casa de Belo Horizonte', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'city': 'Arapongas', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Norte Paranaense', 'geoPoint': {'lat': -23.41944, 'lon': -51.42444}}, {'zip': '83430-000', 'city': 'Campina Grande do Sul', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital e Maternidade Angelina Caron', 'geoPoint': {'lat': -25.30556, 'lon': -49.05528}}, {'city': 'Campo Largo', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Nossa Senhora do Rocio de Campo Largo', 'geoPoint': {'lat': -25.45955, 'lon': -49.53014}}, {'city': 'Cascavel', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Universitário de Cascavel do Oeste do Paraná', 'geoPoint': {'lat': -24.95583, 'lon': -53.45528}}, {'zip': '85864-380', 'city': 'Foz do Iguaçu', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Municipal Padre Germano Lauk', 'geoPoint': {'lat': -25.54778, 'lon': -54.58806}}, {'city': 'Guarapuava', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital São Vicente de Paulo Guarapuava', 'geoPoint': {'lat': -25.39048, 'lon': -51.46541}}, {'city': 'Londrina', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Evangélico de Londrina', 'geoPoint': {'lat': -23.31028, 'lon': -51.16278}}, {'city': 'Londrina', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Universitário Regional do Norte do Paraná', 'geoPoint': {'lat': -23.31028, 'lon': -51.16278}}, {'city': 'Maringá', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Santa Rita de Maringá', 'geoPoint': {'lat': -23.42528, 'lon': -51.93861}}, {'city': 'Maringá', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Universitário de Maringá', 'geoPoint': {'lat': -23.42528, 'lon': -51.93861}}, {'city': 'Maringá', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Irmandade Santa Casa de Misericórdia de Maringá', 'geoPoint': {'lat': -23.42528, 'lon': -51.93861}}, {'city': 'Ponta Grossa', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Bom Jesus de Ponta Grossa', 'geoPoint': {'lat': -25.095, 'lon': -50.16194}}, {'city': 'Ponta Grossa', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Universitario Regional dos Campos Gerais', 'geoPoint': {'lat': -25.095, 'lon': -50.16194}}, {'city': 'Toledo', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Bom Jesus de Toledo', 'geoPoint': {'lat': -24.71361, 'lon': -53.74306}}, {'city': 'João Pessoa', 'state': 'Paraíba', 'country': 'Brazil', 'facility': 'Alberto Urquiza Wanderley - Unimed João Pessoa', 'geoPoint': {'lat': -7.115, 'lon': -34.86306}}, {'city': 'Petrolina', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Hospital de Ensino Doutor Washington Antônio de barros', 'geoPoint': {'lat': -9.39861, 'lon': -40.50083}}, {'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Hospital da Restauração', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'city': 'Nova Iguaçu', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Geral de Nova Iguaçu', 'geoPoint': {'lat': -22.75917, 'lon': -43.45111}}, {'city': 'Canoas', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Canoas', 'geoPoint': {'lat': -29.91778, 'lon': -51.18361}}, {'city': 'Lajeado', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Bruno Born', 'geoPoint': {'lat': -29.46694, 'lon': -51.96139}}, {'city': 'Passo Fundo', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital São Vicente de Paulo', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}, {'city': 'Pelotas', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Universitário São Francisco de Paula', 'geoPoint': {'lat': -31.76997, 'lon': -52.34101}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Cristo Redentor', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Pronto Socorro de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Irmandade da Santa Casa de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Porto Velho', 'state': 'Rondônia', 'country': 'Brazil', 'facility': 'Hospital de Pronto Socorro João Paulo II', 'geoPoint': {'lat': -8.76194, 'lon': -63.90389}}, {'city': 'Aracaju', 'state': 'Sergipe', 'country': 'Brazil', 'facility': 'Hospital de Urgência de Sergipe', 'geoPoint': {'lat': -10.91111, 'lon': -37.07167}}, {'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas de Botucatu', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}, {'city': 'Bragança Paulista', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Universitário São Francisco da Providência de Deus de Bragança Paulista', 'geoPoint': {'lat': -22.9527, 'lon': -46.54418}}, {'city': 'Praia Grande', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Municipal Irmã Dulce', 'geoPoint': {'lat': -24.00583, 'lon': -46.40278}}, {'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'city': 'Santos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Casa de Saúde de Santos', 'geoPoint': {'lat': -23.96083, 'lon': -46.33361}}, {'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital de Base de São José do Rio Preto', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'city': 'Sorocaba', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Irmandade Santa Casa de Misericórdia de Sorocaba', 'geoPoint': {'lat': -23.50167, 'lon': -47.45806}}, {'city': 'Taubaté', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Regional do Vale do Paraíba', 'geoPoint': {'lat': -23.02639, 'lon': -45.55528}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Estadual Getúlio Vargas', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Beneficência Portuguesa de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Geral de Taipas', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Paulistano', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Irmandade da Santa Casa de Misericórdia de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Glauco Westphal, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Moinhos de Vento'}, {'name': 'Regis G Rosa, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Moinhos de Vento'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Moinhos de Vento', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Brazil', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}