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

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

Study Description

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

• 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

Groups and Cohorts

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

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

• 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

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
• Other Study ID Numbers: C806001
• First Posted: July 17, 2008
• 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:

Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating