Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT04002505
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-11
First Post:
2019-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The "Concussion or Brain Bleed" Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006259', 'term': 'Craniocerebral Trauma'}], 'ancestors': [{'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 370}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2019-06-27', 'studyFirstSubmitQcDate': '2019-06-27', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of CT Scans', 'timeFrame': '6 months', 'description': 'Number of CT scans performed when using the Concussion and Brain Bleed app'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials (open in google chrome)'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying to understand the effect of educating patients and encouraging shared decision making on rates of CT scanning in head injured patients by using an already developed app and observing the effect on the health care provider.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old\n* Present to the Emergency Department with a blunt head injury within the past 24 hours\n* Determined to be low risk by the Canadian CT Head Rules (CCHR), and are being considered for a head CT by the treating provider.\n\nExclusion Criteria:\n\n* Patients who are pregnant\n* Non-English speaking\n* In police custody\n* Undergoing psychiatric evaluation\n* Found to have drug or alcohol intoxication'}, 'identificationModule': {'nctId': 'NCT04002505', 'briefTitle': 'The "Concussion or Brain Bleed" Trial', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Shared Decision Making for Patients With Minor Head Injury: The "Concussion or Brain Bleed" Trial', 'orgStudyIdInfo': {'id': '19-000224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Head Injury Subject', 'description': 'Subjects that present to the Emergency Department with a blunt head injury within the past 24 hours, determined to be low risk by the Canadian CT Head Rules (CCHR), and are being considered for a head CT by the treating provider will use the shared decision making tool Concussion and Brain Bleed app (CBC) with their clinician', 'interventionNames': ['Other: Concussion and Brain Bleed App (CBB)']}], 'interventions': [{'name': 'Concussion and Brain Bleed App (CBB)', 'type': 'OTHER', 'description': 'Tablet based decision aid that encourages shared decision making with the goal of educating patients to reduce unnecessary CT scans', 'armGroupLabels': ['Head Injury Subject']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Neha Raukar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Neha P. Raukar', 'investigatorAffiliation': 'Mayo Clinic'}}}}