S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury
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Purpose
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.
| Condition |
|---|
|
Traumatic Brain Injury |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Accuracy of S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury |
- Head CT scan [ Time Frame: At time of injury in ED ] [ Designated as safety issue: No ]
- Post concussive symptoms [ Time Frame: One month after injury ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Serum
| Enrollment: | 1252 |
| Study Start Date: | September 2008 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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)
Contacts and Locations| United States, New York | |
| Albany Medical College | |
| Albany, New York, United States, 12208 | |
| Erie County Medical Center | |
| Buffalo, New York, United States, 14215 | |
| Bassett Healthcare | |
| Cooperstown, New York, United States, 13326 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| SUNY Upstate Medical Center at Syracuse | |
| Syracuse, New York, United States, 13210 | |
| United States, Pennsylvania | |
| Guthrie | |
| Sayre, Pennsylvania, United States, 18840 | |
| Principal Investigator: | Jeffrey J Bazarian, MD, MPH | University of Rochester |
More Information
No publications provided
| Responsible Party: | Jeffrey J. Bazarian, MD, MPH, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00717301 History of Changes |
| Other Study ID Numbers: | C806001 |
| Study First Received: | July 15, 2008 |
| Last Updated: | August 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Rochester:
|
TBI, traumatic brain injury, S100B, head CT scan |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013