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

Tracking Information

First Received Date ^ICMJE

July 15, 2008

Last Updated Date

August 26, 2009

Start Date ^ICMJE

September 2008

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Head CT scan [ Time Frame: At time of injury in ED ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00717301 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Post concussive symptoms [ Time Frame: One month after injury ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort, Time Perspective: Prospective

Condition ^ICMJE

Traumatic Brain Injury

Intervention ^ICMJE

Study Arms / Comparison Groups

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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

2020

Estimated Completion Date

March 2010

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sohug Mookerjee, BS	5852757453	sohug_mookerjee@urmc.rochester.edu
Contact: Jeffrey J Bazarian, MD, MPH	5854632928	jeff_bazarian@urmc.rochester.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00717301

Responsible Party

Jeffrey J. Bazarian, MD, MPH, University of Rochester

Study ID Numbers ^ICMJE

C806001

Study Sponsor ^ICMJE

University of Rochester

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Jeffrey J Bazarian, MD, MPH

University of Rochester

Information Provided By

University of Rochester

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP