S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury
This study has been completed.
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 (Responsible Party):
Jeffrey Bazarian, University of Rochester
ClinicalTrials.gov Identifier:
NCT00717301
First received: July 15, 2008
Last updated: June 10, 2015
Last verified: June 2015
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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 |
Resource links provided by NLM:
Further study details as provided by University of Rochester:
Primary Outcome Measures:
- Head CT scan [ Time Frame: At time of injury in ED ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717301
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717301
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 | |
Sponsors and Collaborators
University of Rochester
Academic Health Center Consortium (not Univ of Minnesota)
New York State Department of Health
Emergency Research Network of the Empire State
Investigators
| Principal Investigator: | Jeffrey J Bazarian, MD, MPH | University of Rochester |
More Information
| Responsible Party: | Jeffrey Bazarian, Professor, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00717301 History of Changes |
| Other Study ID Numbers: | C806001 |
| Study First Received: | July 15, 2008 |
| Last Updated: | June 10, 2015 |
| 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:
|
Wounds and Injuries Brain Injuries Brain Concussion Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Head Injuries, Closed Wounds, Nonpenetrating |
ClinicalTrials.gov processed this record on September 23, 2016