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S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury

Accuracy of S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00717301
Enrollment
1252
Registered
2008-07-17
Start date
2008-09-30
Completion date
2010-09-30
Last updated
2015-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

TBI, traumatic brain injury, S100B, head CT scan

Brief 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 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.

Interventions

None listed

Sponsors

Academic Health Center Consortium (not Univ of Minnesota)
CollaboratorUNKNOWN
New York State Department of Health
CollaboratorOTHER_GOV
Emergency Research Network of the Empire State
CollaboratorUNKNOWN
University of Rochester
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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 * 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)

Design outcomes

Primary

MeasureTime frame
Head CT scanAt time of injury in ED

Secondary

MeasureTime frame
Post concussive symptomsOne month after injury

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026