Mild Traumatic Brain Injury Registry

NCT01688869 | Completed DMC

• 1 other identifier: 04-12-03A
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury, Traumatic

Keywords

brain concussion

Outcome Measures

Primary Outcomes (1)

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

  6 months

Study Arms (1)

Mild TBI

Patients who have been diagnosed with a mild brain injury.

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be obtained in the emergency room and processed for future analysis. Depending on the blood volume obtained, up to two citrate, two EDTA, and one Paxgene tube will be collected.

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Lori M Grafton, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Michael A Gibbs, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 20, 2012
• Study Start: April 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 25, 2022

Record last verified: 2015-02

Locations

US (1)