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

This study has been completed.

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

ClinicalTrials.gov Identifier:

NCT00717301

First received: July 15, 2008

Last updated: June 10, 2015

Last verified: June 2015

History of Changes

Purpose

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
Traumatic Brain Injury


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Accuracy of S-100B as Pre-Head CT Scan Screening Test After Mild Traumatic Brain Injury

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Concussion Nuclear Scans Traumatic Brain Injury

U.S. FDA Resources

Further study details as provided by Jeffrey Bazarian, University of Rochester:

Primary Outcome Measures:

Head CT scan [ Time Frame: At time of injury in ED ]

Secondary Outcome Measures:

Post concussive symptoms [ Time Frame: One month after injury ]

Biospecimen Retention: Samples Without DNA

Serum


Enrollment:	1252
Study Start Date:	September 2008
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Jeffrey Bazarian, Professor, University of Rochester
ClinicalTrials.gov Identifier:	NCT00717301 History of Changes
Other Study ID Numbers:	C806001
Study First Received:	July 15, 2008
Last Updated:	June 10, 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 Concussion Brain Diseases Central Nervous System Diseases	Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Head Injuries, Closed Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on June 26, 2017

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