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OpenTrials
Completed

NCT Number: NCT01688869

Mild Traumatic Brain Injury Registry

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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Key information

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Acronym: mTBI

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 20, 2012
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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