Mild Traumatic Brain Injury Registry (mTBI)

This study is currently recruiting participants.
Verified October 2013 by Carolinas Healthcare System
Sponsor:
Information provided by (Responsible Party):
Lori Grafton, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01688869
First received: September 17, 2012
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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
Brain Injury, Traumatic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mild Traumatic Brain Injury Registry

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 400
Study Start Date: April 2012
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Mild TBI
Patients who have been diagnosed with a mild brain injury.

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

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01688869

Contacts
Contact: Carla Kingsbury, B.S. 704-355-1057
Contact: Virginia Krabill, B.S., RN 704-355-3841

Locations
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Carla Kingsbury    704-355-1057      
Principal Investigator: Lori M Grafton, MD         
Principal Investigator: Michael A Gibbs, MD         
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Lori M Grafton, MD Carolinas Healthcare System
Principal Investigator: Michael A Gibbs, MD Carolinas Healthcare System
  More Information

No publications provided

Responsible Party: Lori Grafton, Co-Principal Investigator, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01688869     History of Changes
Other Study ID Numbers: 04-12-03A
Study First Received: September 17, 2012
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
brain concussion

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 15, 2014