Mild Traumatic Brain Injury Registry (mTBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01688869
Recruitment Status : Completed
First Posted : September 20, 2012
Last Update Posted : February 10, 2015
Information provided by (Responsible Party):
Lori Grafton, Carolinas Healthcare System

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.

Condition or disease
Brain Injury, Traumatic

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.

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mild Traumatic Brain Injury Registry
Study Start Date : April 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Mild TBI
Patients who have been diagnosed with a mild brain injury.

Primary Outcome Measures :
  1. To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury. [ Time Frame: 6 months ]

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01688869

United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Carolinas Healthcare System
Principal Investigator: Lori M Grafton, MD Carolinas Healthcare System
Principal Investigator: Michael A Gibbs, MD Carolinas Healthcare System

Responsible Party: Lori Grafton, Co-Principal Investigator, Carolinas Healthcare System Identifier: NCT01688869     History of Changes
Other Study ID Numbers: 04-12-03A
First Posted: September 20, 2012    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Keywords provided by Lori Grafton, Carolinas Healthcare System:
brain concussion

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating