Mild Traumatic Brain Injury Registry

Completed

• Conditions: Brain Injury, Traumatic

• Registration Number: NCT01688869
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-20
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-02
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury.	6 months

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States