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Clinical Trials/NCT01688869
NCT01688869
Completed
Not Applicable

Mild Traumatic Brain Injury Registry

Wake Forest University Health Sciences1 site in 1 country40 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Injury, Traumatic
Sponsor
Wake Forest University Health Sciences
Enrollment
40
Locations
1
Primary Endpoint
To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury.
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of the study is to gather information about patients with mild traumatic brain injury in order to develop guidelines for evaluation and treatment.

Detailed Description

The Mild Traumatic Brain Injury Registry is a prospective study which includes patients who have been seen in the CMC ED with a diagnosis of mild brain injury or concussion and a negative CT scan. The investigators will be collecting blood samples, and administering cognitive and balance tests. The investigators will also be following symptoms and cognition throughout the first year to help define typical recovery, and guide prognosis.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
January 2015
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Must have defined history of CHI (closed head injury) which produced an altered state of consciousness or mood
  • Must be awake and alert (Glasgow Coma Scale 13-15)
  • Must be enrolled within 72 hours of injury
  • Must have CT or MRI neuroimaging performed

Exclusion Criteria

  • Diabetes Mellitus with severe complications
  • Intoxication at time of enrollment
  • Major psychiatric disorder that is poorly controlled
  • Prior stroke
  • History of Social Security defined "disability
  • Uncontrolled Seizure Disorder
  • Incarceration or arrest
  • Concurrent Injury requiring hospitalization
  • Use of anticoagulant drugs
  • Any condition the investigator deems as inappropriate for patient enrollment

Outcomes

Primary Outcomes

To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury.

Time Frame: 6 months

Study Sites (1)

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