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OpenTrials
Completed

NCT Number: NCT00717301

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

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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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Albany Medical College, Albany, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Head CT scan

    Time frame: At time of injury in ED

Secondary outcomes

  1. Post concussive symptoms

    Time frame: One month after injury

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Academic Health Center Consortium (not Univ of Minnesota)
  • Emergency Research Network of the Empire State
  • New York State Department of Health

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 17, 2008
Registry last updated
Jun 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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