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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717301
• Other study ID #: C806001
• Status: Completed
• Phase: N/A
• First received: July 15, 2008
• Last updated: June 10, 2015
• Start date: September 2008
• Est. completion date: September 2010

Study information

• Verified date: June 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1252
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	Erie County Medical Center	Buffalo	New York
United States	Bassett Healthcare	Cooperstown	New York
United States	University of Rochester Medical Center	Rochester	New York
United States	Guthrie	Sayre	Pennsylvania
United States	SUNY Upstate Medical Center at Syracuse	Syracuse	New York

Sponsors (4)

Lead Sponsor	Collaborator
University of Rochester	Academic Health Center Consortium (not Univ of Minnesota), Emergency Research Network of the Empire State, New York State Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Head CT scan		At time of injury in ED	No
Secondary	Post concussive symptoms		One month after injury	No