Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-01 @ 8:26 AM
Study NCT ID:
NCT01225692
Status:
COMPLETED
Last Update Posted:
2010-10-21
First Post:
2010-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Trauma Outcomes in Nova Scotia Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-20', 'studyFirstSubmitDate': '2010-10-15', 'studyFirstSubmitQcDate': '2010-10-20', 'lastUpdatePostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Measurement; Hours:minutes', 'description': 'Time as measured by ; Time Elapsed from Injury Time to Time of Arrival at Tertiary Care'}], 'secondaryOutcomes': [{'measure': 'Clinical Follow-up; Numerical Score 1-5;Glasgow Outcome Scores (GOS)', 'description': 'Glasgow Outcome Scores (GOS)\n\nScore ranges from:\n\n5 Good Recovery (Resumption of normal life despite minor deficits) 4 Moderate Disability(Disabled but independent. Can work in sheltered setting) 3 Severe Disability (Conscious but disabled. Dependent for daily support) 2 Persistent vegetative (Minimal responsiveness)\n\n1 Death (Non survival)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Brain Injury', 'Head Trauma', 'Trauma Systems', 'Head Injury Guideline', 'Time to Tertiary Care'], 'conditions': ['Brain Injuries,Traumatic', 'Outcome Assessment (Health Care)', 'Craniocerebral Trauma', 'Emergency Medical Services', 'Organizational Innovation']}, 'descriptionModule': {'briefSummary': "The goals of this study are to identify outcome indicators of optimal care for brain injury patients, including pre-hospital care, prompt delivery to neurosurgical care and access to early rehabilitation services. Nova Scotia's centralized Neurosurgical services and integrated provincial Emergency Health Services provide a rich opportunity to construct a cohesive, integrated data management system. This system will allow us to answer important research questions related to the outcomes, care and prevention of brain trauma.\n\nRetrospective data collection The retrospective arm of the BTO study has created full data sets and care pathways from multiple sources covering the continuum of brain trauma care. Investigators continue to analyze this large amount of data and prepare it for publication.\n\nProspective data Collection Patients with a major head injury (initial GCS 3-12), have been considered for enrollment in the BTO study.The prospective arm of the BTO study has 52 patients enrolled. Screening and Enrollment was complete on June 30, 2007. These patients are participating in long term follow up at 6, 12 and 24 months post injury for assessment of qualitative and quantitative outcomes. Completion of patient follow up will be in June 2009."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': "Retrospective Arm Cohort 1: AIS ≥ 3, head +/- other injuries Cohort 2: AIS ≥ 3, isolated head injury (cohort 2 is a subset of cohort 1)\n\nInclusion Criteria:\n\n1.patient treated in at least one facility prior to arrival at QEII.\n\nExclusion Criteria\n\n1. injured out of province\n2. time from injury to 1st facility presentation known to be \\> 24 hours\n3. time arrival at 1st referring facility to time arrive at QEII known to be \\> 24 hours\n4. direct ground or air scene transport\n\nProspective Arm:\n\nInclusion Criteria:\n\n1. have a head injury requiring hospital admission\n2. able to provide informed consent or have next- of -kin able to provide consent on patients' behalf\n\nExclusion Criteria:\n\n1\\. unwilling or unable to provide consent"}, 'identificationModule': {'nctId': 'NCT01225692', 'acronym': 'BTOS', 'briefTitle': 'Brain Trauma Outcomes in Nova Scotia Study', 'organization': {'class': 'OTHER', 'fullName': 'Queen Elizabeth II Health Sciences Centre'}, 'officialTitle': 'Brain Trauma Outcomes in Nova Scotia', 'orgStudyIdInfo': {'id': 'CDHA-RS/2004-014'}, 'secondaryIdInfos': [{'id': 'PSO-Project- 2003-353', 'type': 'OTHER_GRANT', 'domain': 'Nova Scotia Health Research Foundation'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Head Injury Guideline', 'type': 'BEHAVIORAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Elizabeth II Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. B. David Clarke', 'oldOrganization': 'QEII HSC,Capital Health, Dalhousie University, Division of Neursosurgery'}}}}