S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury
Accuracy of S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury
1 other identifier
observational
1,252
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2008
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2008
CompletedFirst Posted
Study publicly available on registry
July 17, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedJune 12, 2015
June 1, 2015
2 years
July 15, 2008
June 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Head CT scan
At time of injury in ED
Secondary Outcomes (1)
Post concussive symptoms
One month after injury
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Albany Medical College
Albany, New York, 12208, United States
Erie County Medical Center
Buffalo, New York, 14215, United States
Bassett Healthcare
Cooperstown, New York, 13326, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY Upstate Medical Center at Syracuse
Syracuse, New York, 13210, United States
Guthrie
Sayre, Pennsylvania, 18840, United States
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey J Bazarian, MD, MPH
University of Rochester
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 15, 2008
First Posted
July 17, 2008
Study Start
September 1, 2008
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
June 12, 2015
Record last verified: 2015-06