Mild Traumatic Brain Injury Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Brain Injury, Traumatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mild TBI

Patients who have been diagnosed with a mild brain injury.

No interventions assigned to this group

Eligibility Criteria

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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
* Personality disorder
* Heart, liver or kidney failure defined using common clinical practice guidelines
* Baseline cognitive impairment
* Homelessness
* TBI associated with interpersonal violence
* Pregnancy
* Long bone fracture requiring surgical stabilization

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No