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S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT00717301
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : June 12, 2015
Sponsor:
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

Study Description
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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.

Condition or disease
Traumatic Brain Injury

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.

Study Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Head CT scan [ Time Frame: At time of injury in ED ]

Secondary Outcome Measures :
  1. Post concussive symptoms [ Time Frame: One month after injury ]

Biospecimen Retention:   Samples Without DNA
Serum

Eligibility Criteria
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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
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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Information from the National Library of Medicine

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


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
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Responsible Party: Jeffrey Bazarian, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00717301     History of Changes
Other Study ID Numbers: C806001
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015

Keywords provided by Jeffrey Bazarian, University of Rochester:
TBI, traumatic brain injury, S100B, head CT scan

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating