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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury

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 Type: Observational
• Enrollment (Actual): 1252

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • Buffalo, New York, United States, 14215
      • Erie County Medical Center
    • Cooperstown, New York, United States, 13326
      • Bassett Healthcare
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical Center at Syracuse
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Head CT scan	At time of injury in ED

Secondary Outcome Measures

Outcome Measure	Time Frame
Post concussive symptoms	One month after injury

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: New York State Department of Health; Academic Health Center Consortium (not Univ of Minnesota); Emergency Research Network of the Empire State
• Investigators: Principal Investigator: Jeffrey J Bazarian, MD, MPH, University of Rochester

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: July 15, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (Estimate): July 17, 2008

Study Record Updates

• Last Update Posted (Estimate): June 12, 2015
• Last Update Submitted That Met QC Criteria: June 10, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: TBI, traumatic brain injury, S100B, head CT scan
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: C806001