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

This study has been completed.
Sponsor:
Collaborators:
Academic Health Center Consortium (not Univ of Minnesota)
New York State Department of Health
Emergency Research Network of the Empire State
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00717301
First received: July 15, 2008
Last updated: August 16, 2011
Last verified: August 2011

July 15, 2008
August 16, 2011
September 2008
September 2010   (final data collection date for primary outcome measure)
Head CT scan [ Time Frame: At time of injury in ED ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00717301 on ClinicalTrials.gov Archive Site
Post concussive symptoms [ Time Frame: One month after injury ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum

Non-Probability Sample

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.

Traumatic Brain Injury
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1252
September 2010
September 2010   (final data collection date for primary outcome measure)

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)

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00717301
C806001
No
Jeffrey J. Bazarian, MD, MPH, University of Rochester
University of Rochester
  • Academic Health Center Consortium (not Univ of Minnesota)
  • New York State Department of Health
  • Emergency Research Network of the Empire State
Principal Investigator: Jeffrey J Bazarian, MD, MPH University of Rochester
University of Rochester
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP