Brain InjuriesNCT04478812
Tbit System Precision and Correlation of Different Blood Samples
A study testing Single Group Assignment in people with Brain Injuries and Traumatic Brain Injury, run by BioDirection Inc.
Trial summary
The Tbit™ System will detect S100B and GFAP concentrations with the blood specimen to produce and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and one 1 venous whole blood sample will be collected from the same subject, on 3 different Tbit™ System by 3 different operators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Traumatic Brain Injury
- What is being tested?
- Single Group Assignment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 30 Nov 2024
- Phase
- Interventional
- 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
Who may be able to join
- At least 18 years of age
- Presents to the Emergency Department with suspected traumatic brain 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 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
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- 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, Blood Collection Study to Evaluate TbitTM System Precision and Correlation Between Different Blood Samples Measured With TbitTM System
The Tbit™ System will detect S100B and GFAP concentrations with the blood specimen to produce and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and one 1 venous whole blood sample will be collected from the same subject, on 3 different Tbit™ System by 3 different operators.
- Conditions
- Brain Injuries, Traumatic Brain Injury
- Being tested
- Single Group Assignment
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Group AssignmentDiagnostic test
Tbit™ System will detect S100B and GFAP concentrations with the blood specimen collected
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Experimental | Not described Receives: Diagnostic Test: Single Group Assignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement Repeatability
- Evaluate the repeatability of measurement of S100B and GFAP concentrations in capillary blood using the Tbit™ System at different clinical sites and between-instrument and between-operator components of variance in the intended use environment.
Measured: within 12 hours from injury for Tbit and within 30 min from the sample drawn
Compare Measurements
- Compare concentrations of S100B and GFAP measured using Tbit™ System in specimens obtained from a fingerstick blood, venous whole blood, serum and plasma in the intended use environment.
Measured: within 12 hours from injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start15 Sep 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 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
- NCT04478812
- Sponsor's protocol ID
- BDI-TBIT-04
- Status last verified
- Apr 2024
- First submitted
- 16 Jul 2020
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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, Blood Collection Study to Evaluate TbitTM System Precision and Correlation Between Different Blood Samples Measured With TbitTM System
- ClinicalTrials.gov ID
- NCT04478812
- Acronym / sponsor ID
- BDI-TBIT-04
- Conditions
- Brain Injuries, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- BioDirection IncIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 21 Jul 2020 (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.
The Tbit™ System will detect S100B and GFAP concentrations with the blood specimen to produce and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and one 1 venous whole blood sample will be collected from the same subject, on 3 different Tbit™ System by 3 different operators.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Experimental | Diagnostic Test: Single Group Assignment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Presents to the Emergency Department with suspected traumatic brain 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 (9 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 |
|---|---|---|
| Single Group AssignmentTbit™ System will detect S100B and GFAP concentrations with the blood specimen collected | Diagnostic test | Single Group Assignment |
Primary outcome
Measurement Repeatability
Time frame: within 12 hours from injury for Tbit and within 30 min from the sample drawn
1. Evaluate the repeatability of measurement of S100B and GFAP concentrations in capillary blood using the Tbit™ System at different clinical sites and between-instrument and between-operator components of variance in the intended use environment.
Compare Measurements
Time frame: within 12 hours from injury
2. Compare concentrations of S100B and GFAP measured using Tbit™ System in specimens obtained from a fingerstick blood, venous whole blood, serum and plasma in the intended use environment.
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.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Single Group Assignment in people with Brain Injuries and Traumatic Brain Injury, 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 4 inclusion and 9 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 Lelia 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?
Measurement Repeatability (time frame: within 12 hours from injury for Tbit and within 30 min from the sample drawn). 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.