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| Sponsor: | University of Rochester |
|---|---|
| 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 |
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: | Cohort, Prospective |
| Official Title: | Accuracy of S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury |
Serum
| Estimated Enrollment: | 2020 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | March 2010 |
| Groups/Cohorts |
|---|
2
|
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:
(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)
Contacts and Locations| Contact: Sohug Mookerjee, BS | 5852757453 | sohug_mookerjee@urmc.rochester.edu |
| Contact: Jeffrey J Bazarian, MD, MPH | 5854632928 | jeff_bazarian@urmc.rochester.edu |
| United States, New York | |
| University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Erie County Medical Center | Recruiting |
| Buffalo, New York, United States, 14215 | |
| SUNY Upstate Medical Center at Syracuse | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Albany Medical College | Recruiting |
| Albany, New York, United States, 12208 | |
| Bassett Healthcare | Recruiting |
| Cooperstown, New York, United States, 13326 | |
| United States, Pennsylvania | |
| Guthrie | Recruiting |
| Sayre, Pennsylvania, United States, 18840 | |
| Principal Investigator: | Jeffrey J Bazarian, MD, MPH | University of Rochester |
More Information
| Responsible Party: | University of Rochester ( Jeffrey J. Bazarian, MD, MPH ) |
| Study ID Numbers: | C806001 |
| Study First Received: | July 15, 2008 |
| Last Updated: | August 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00717301 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
TBI, traumatic brain injury, S100B, head CT scan |
|
Craniocerebral Trauma Nervous System Diseases Wounds and Injuries Disorders of Environmental Origin |
Central Nervous System Diseases Trauma, Nervous System Brain Diseases Brain Injuries |