Traumatic Brain InjuryNCT00717301
S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by University of Rochester at 6 sites in United States.
Trial summary
The purpose of the study is to determine if a specific blood protein, S-100B, can help predict who will have a traumatic abnormality on head CT scan after a concussion. We will compare the levels of this protein in the subject's blood to the initial head CT scan and to how the subject is feeling one month after… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 1,252 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2008to Sep 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting to Emergency Departments that are a part of the AHCC (Academic Health Center Consortium) and/or ERNES (Emergency Research Network of the Empire State) networks.
Who may be able to join
- Patients presenting with head trauma to any of the AHCC/ERNES EDs, meeting the following criteria will be eligible to participate:
- Presence of mild TBI per study definition
- Arrival at the ED within 4 hours of injury
- ED workup includes a Head CT
- (Controls are eligible if they present to the Outpatient Lab for routine bloodwork during enrollment hours)
Who cannot join
- Time of injury not able to be determined
- Head CT not done as part of clinical emergency care
- Incarcerated
- Non-English or Spanish speakers
- Absence of parent/guardian for minor subjects
- Subject and/or parent/guardian do not have capacity to consent
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- Head injury due to birth trauma, anoxia, inflammatory, toxic, infectious or metabolic encephalopathies that are not complications of head trauma
- Ischemic or hemorrhagic stroke without associated trauma
- (Controls are excluded if they have any of the following:History of brain tumor, melanoma and/or Alzheimer's disease; History of concussion, bone fracture or stroke (CVA or TIA) in the past month; History of surgery in the past month; Inability to obtain consent from subject and/or parent due to lack of capacity or absence of parent/guardian of minor; Inability to speak or read English; Incarceration)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Albany Medical College
Albany, New York, 12208
Erie County Medical Center
Buffalo, New York, 14215
Bassett Healthcare
Cooperstown, New York, 13326
University of Rochester Medical Center
Rochester, New York, 14642
Guthrie
Sayre, Pennsylvania, 18840
SUNY Upstate Medical Center at Syracuse
Syracuse, New York, 13210
About this study
Official title: Accuracy of S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury
The purpose of the study is to determine if a specific blood protein, S-100B, can help predict who will have a traumatic abnormality on head CT scan after a concussion. We will compare the levels of this protein in the subject's blood to the initial head CT scan and to how the subject is feeling one month after injury. We hope that the information we collect in this trial will help us determine who needs a head CT scan after a concussion and who may be more likely to have trouble recovering from a concussion.
Read the detailed description
The primary objective of this study is to determine the ability of a serum S-100B to predict traumatic abnormalities on brain CT scan after mild traumatic brain injury (mild TBI). The secondary objective is to determine the relationship between initial S-100B levels and cognitive outcome at one month.
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI, traumatic brain injury, S100B, head CT scan
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Head Trauma | Patients presenting to any of the AHCC/ERNES Emergency Departments with head trauma. | |
| Control subjects | Patients presenting to the Univ of Rochester Medical Center/Strong Memorial Hospital Outpatient Laboratory for routine blood draw. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head CT scan
Measured: At time of injury in ED
Secondary outcomes (1)
Post concussive symptoms
Measured: One month after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- 1,252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Health Center Consortium (not Univ of Minnesota), New York State Department of Health, Emergency Research Network of the Empire State
- Responsible party
- Principal investigator, Jeffrey Bazarian, University of Rochester
- Investigators
- Jeffrey J Bazarian, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717301
- Sponsor's protocol ID
- C806001
- Status last verified
- Jun 2015
- First submitted
- 15 Jul 2008
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00717301
- Acronym / sponsor ID
- C806001
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI, traumatic brain injury, S100B, head CT scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,252 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Academic Health Center Consortium (not Univ of Minnesota), New York State Department of Health, Emergency Research Network of the Empire State
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Jul 2008 (estimated)
- 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 purpose of the study is to determine if a specific blood protein, S-100B, can help predict who will have a traumatic abnormality on head CT scan after a concussion. We will compare the levels of this protein in the subject's blood to the initial head CT scan and to how the subject is feeling one month after injury. We hope that the information we collect in this trial will help us determine who needs a head CT scan after a concussion and who may be more likely to have trouble recovering from a concussion.
Detailed description
The primary objective of this study is to determine the ability of a serum S-100B to predict traumatic abnormalities on brain CT scan after mild traumatic brain injury (mild TBI). The secondary objective is to determine the relationship between initial S-100B levels and cognitive outcome at one month.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head Trauma | – | –Patients presenting to any of the AHCC/ERNES Emergency Departments with head trauma. |
| Control subjects | – | –Patients presenting to the Univ of Rochester Medical Center/Strong Memorial Hospital Outpatient Laboratory for routine blood draw. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting to Emergency Departments that are a part of the AHCC (Academic Health Center Consortium) and/or ERNES (Emergency Research Network of the Empire State) networks.
Key inclusion criteria (5 listed)
- Patients presenting with head trauma to any of the AHCC/ERNES EDs, meeting the following criteria will be eligible to participate:
- (Controls are eligible if they present to the Outpatient Lab for routine bloodwork during enrollment hours)
Key exclusion criteria (9 listed)
- Time of injury not able to be determined
- Head CT not done as part of clinical emergency care
- Incarcerated
- Non-English or Spanish speakers
- Absence of parent/guardian for minor subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Head CT scan
Time frame: At time of injury in ED
1 secondary outcome
Post concussive symptoms
Time frame: One month after injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
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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.
Jeffrey J Bazarian, MD, MPH principal investigator
University of Rochester
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by University of Rochester at 6 sites in United States.
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 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: finished, as of the sponsor's last update on 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Head CT scan (time frame: At time of injury in ED). 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 12 Jun 2015; AzTrials last refreshed its copy on 28 Oct 2026.