S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury
| Tracking Information | |||||
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| First Received Date ICMJE | July 15, 2008 | ||||
| Last Updated Date | August 16, 2011 | ||||
| Start Date ICMJE | September 2008 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Head CT scan [ Time Frame: At time of injury in ED ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00717301 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Post concussive symptoms [ Time Frame: One month after injury ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury | ||||
| Official Title ICMJE | Accuracy of S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury | ||||
| 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 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Serum |
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| 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. |
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| Condition ICMJE | Traumatic Brain Injury | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1252 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
(Controls are eligible if they present to the Outpatient Lab for routine bloodwork during enrollment hours) Exclusion Criteria:
(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) |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00717301 | ||||
| Other Study ID Numbers ICMJE | C806001 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jeffrey J. Bazarian, MD, MPH, University of Rochester | ||||
| Study Sponsor ICMJE | University of Rochester | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Rochester | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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