Clinical trial NCT01688869: Mild Traumatic Brain Injury Registry
Official title: Mild Traumatic Brain Injury Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injury, Traumatic
Keywords: brain concussion
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2012-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are seen in the CMC emergency department who have a clearly defined history of traumatic brain injury that produced at least transient alteration in consciousness, or change in mood, together with one or more persistent symptom lasting longer than one hour after impact. Symptoms can include head pain, nausea, dizziness, disequilibrium, confusion, amnesia, or irritability. All patients must be awake and alert (GCS 13 to 15), and must be enrolled within 72 hours of the injury.

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.

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
* 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

Primary outcomes:
measure: To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Lori M Grafton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Michael A Gibbs, MD
role: PRINCIPAL_INVESTIGATOR
References: