S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00717301 |
Recruitment Status :
Completed
First Posted : July 17, 2008
Last Update Posted : June 12, 2015
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Condition or disease |
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Traumatic Brain Injury |
Study Type : | Observational |
Actual Enrollment : | 1252 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Accuracy of S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |

Group/Cohort |
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Head Trauma
Patients presenting to any of the AHCC/ERNES Emergency Departments with head trauma.
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Control subjects
Patients presenting to the Univ of Rochester Medical Center/Strong Memorial Hospital Outpatient Laboratory for routine blood draw.
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- Head CT scan [ Time Frame: At time of injury in ED ]
- Post concussive symptoms [ Time Frame: One month after injury ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717301
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 |
Responsible Party: | Jeffrey Bazarian, Professor, University of Rochester |
ClinicalTrials.gov Identifier: | NCT00717301 |
Other Study ID Numbers: |
C806001 |
First Posted: | July 17, 2008 Key Record Dates |
Last Update Posted: | June 12, 2015 |
Last Verified: | June 2015 |
TBI, traumatic brain injury, S100B, head CT scan |
Brain Injuries Brain Injuries, Traumatic Brain Concussion Wounds and Injuries Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Head Injuries, Closed Wounds, Nonpenetrating |