Status:
COMPLETED
S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Academic Health Center Consortium (not Univ of Minnesota)
New York State Department of Health
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
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 t...
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 object...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
1252 Patients enrolled
Trial Details
Trial ID
NCT00717301
Start Date
September 1 2008
End Date
September 1 2010
Last Update
June 12 2015
Active Locations (6)
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1
Albany Medical College
Albany, New York, United States, 12208
2
Erie County Medical Center
Buffalo, New York, United States, 14215
3
Bassett Healthcare
Cooperstown, New York, United States, 13326
4
University of Rochester Medical Center
Rochester, New York, United States, 14642