Brain Injuries, TraumaticNCT04107662
Biomarkers of Traumatic Brain Injury With Tbit System
An observational study of Brain Injuries, Traumatic, run by BioDirection Inc.
Trial summary
A prospective, multi-center, non-randomized, pivotal study to assess the safety and efficacy of the Tbit™ System to aid in patient evaluation, suspected of traumatic brain injury, as adjunct companion test to radiologic standard of care, Cranial Computerized Tomography (CCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Tbit system
- Type of treatment
- Medical device
- How many people
- 740 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 30 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female participants (≥18 years of age) that present to the Emergency Department with suspected non-penetrating blunt trauma within 24 hours from injury and who receive a CT scan as a standard of care.
Who may be able to join
- At least 18 years of age
- 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)
Who cannot join
- Suspect of ischemic or hemorrhagic stroke with subsequent incidental trauma based on ED examination
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multi-Center, Non-Randomized Study to Identify Intracranial Hemorrhage by Using an In-Vitro Device, Tbit™ System
A prospective, multi-center, non-randomized, pivotal study to assess the safety and efficacy of the Tbit™ System to aid in patient evaluation, suspected of traumatic brain injury, as adjunct companion test to radiologic standard of care, Cranial Computerized Tomography (CCT).
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Tbit system
- Keywords
- brain, injuries, disease, trauma, nervous system, wounds
- Medical subject headings
- Brain Injuries, Traumatic, Wounds and Injuries, Disease, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tbit systemDevice
Also called Head CT scan and blood draw within 12 hours of injury
Suspected traumatic brain injury with head CT
| Study group | Role | What they receive |
|---|---|---|
| Traumatic Brain Injury | Not described Receives: Device: Tbit system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cranial CT Intracranial Hemorrhage findings and the binary Tbit™ System (positive/negative)
Cranial CT Intracranial Hemorrhage findings (positive/negative) and the binary Tbit™ System results (positive/negative) of each sample.
Measured: within 12 hours from injury on day 0 of ED presentation
Tbit™ System sensitivity and specificity
Tbit™ System sensitivity and specificity relative to the standard-of-care (SOC)
Measured: within 12 hours from injury on day 0 of ED presentation
Secondary outcomes (4)
Negative predictive value of the Tbit™ System
Negative predictive value of the Tbit™ System
Measured: within 12 hours from injury on day 0 of ED presentation
Positive predictive value of the Tbit™ System
Positive predictive value of the Tbit™ System
Measured: within 12 hours from injury on day 0 of ED presentation
Overall accuracy of the Tbit™ System
Overall accuracy of the Tbit™ System
Measured: within 12 hours from injury on day 0 of ED presentation
Safety and adverse event profile
Safety and adverse event profile
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Dec 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioDirection Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerika Acosta, BSc, Study director, Medicept Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107662
- Sponsor's protocol ID
- BDI-TBIT-03
- Status last verified
- Apr 2024
- First submitted
- 17 Sep 2019
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Non-Randomized Study to Identify Intracranial Hemorrhage by Using an In-Vitro Device, Tbit™ System
- ClinicalTrials.gov ID
- NCT04107662
- Acronym / sponsor ID
- BDI-TBIT-03
- Conditions
- Brain Injuries, Traumatic
- Keywords
- brain, injuries, disease, trauma, nervous system, wounds
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 740 participants (estimated)
- Lead sponsor
- BioDirection IncIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multi-center, non-randomized, pivotal study to assess the safety and efficacy of the Tbit™ System to aid in patient evaluation, suspected of traumatic brain injury, as adjunct companion test to radiologic standard of care, Cranial Computerized Tomography (CCT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic Brain Injury | – | Device: Tbit system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female participants (≥18 years of age) that present to the Emergency Department with suspected non-penetrating blunt trauma within 24 hours from injury and who receive a CT scan as a standard of care.
Key inclusion criteria (5 listed)
- At least 18 years of age
- 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)
Key exclusion criteria (10 listed)
- Suspect of ischemic or hemorrhagic stroke with subsequent incidental trauma based on ED examination
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tbit systemAlso: Head CT scan and blood draw within 12 hours of injurySuspected traumatic brain injury with head CT | Device | Traumatic Brain Injury |
Primary outcome
Cranial CT Intracranial Hemorrhage findings and the binary Tbit™ System (positive/negative)
Time frame: within 12 hours from injury on day 0 of ED presentation
Cranial CT Intracranial Hemorrhage findings (positive/negative) and the binary Tbit™ System results (positive/negative) of each sample.
Tbit™ System sensitivity and specificity
Time frame: within 12 hours from injury on day 0 of ED presentation
Tbit™ System sensitivity and specificity relative to the standard-of-care (SOC)
4 secondary outcomes
Negative predictive value of the Tbit™ System
Time frame: within 12 hours from injury on day 0 of ED presentation
Positive predictive value of the Tbit™ System
Time frame: within 12 hours from injury on day 0 of ED presentation
Overall accuracy of the Tbit™ System
Time frame: within 12 hours from injury on day 0 of ED presentation
Safety and adverse event profile
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerika Acosta, BSc study director
Medicept Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by BioDirection Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adelina A Paunescu, PhD (7815268152, apaunescu@medicept.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cranial CT Intracranial Hemorrhage findings and the binary Tbit™ System (positive/negative) (time frame: within 12 hours from injury on day 0 of ED presentation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.