Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
740 participants
OBSERVATIONAL
2024-12-01
2025-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Traumatic Brain Injury
Tbit system
Suspected traumatic brain injury with head CT
Interventions
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Tbit system
Suspected traumatic brain injury with head CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presents to the Emergency Department with suspected traumatic brain injury
* Prescribed a non-contrast CCT as part of routine emergency care within 24 hours from injury
* Blood sample collected for Tbit™ System within 12 hours of injury
* Willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)
Exclusion Criteria
* Subject suspect of need of craniotomy for the acute trauma for this event
* External signs compatible with a depressed skull fracture based on ED exam
* Subject requiring administration of blood transfusion after injury and prior to study blood draw
* Subject for whom timing of injury is unable to be estimated within 1 hour of certainty
* Subject with a condition precluding entry into the CT scanner
* Subject who had neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizures, brain tumors, stroke or TIA within the last 30 days, or history of neurosurgery
* Known or suspected to be pregnant
* Prisoner or under incarceration
* Participating in another clinical research study prior to this study completion
18 Years
ALL
No
Sponsors
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BioDirection Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Jerika Acosta, BSc
Role: STUDY_DIRECTOR
Medicept Inc.
Central Contacts
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Other Identifiers
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BDI-TBIT-03
Identifier Type: -
Identifier Source: org_study_id
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