Mild Traumatic Brain Injury Registry (mTBI)
This study has been completed.
Information provided by (Responsible Party):
Lori Grafton, Carolinas Healthcare System
First received: September 17, 2012
Last updated: February 9, 2015
Last verified: February 2015
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Mild Traumatic Brain Injury Registry
Biospecimen Retention: Samples With DNA
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 ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
Patients who have been diagnosed with a mild brain injury.
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.
|Ages Eligible for Study:
||16 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
- 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
- TBI associated with interpersonal violence
- Long bone fracture requiring surgical stabilization
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01688869
|Carolinas Medical Center
|Charlotte, North Carolina, United States, 28203 |
Carolinas Healthcare System
||Lori M Grafton, MD
||Carolinas Healthcare System
||Michael A Gibbs, MD
||Carolinas Healthcare System
No publications provided
||Lori Grafton, Co-Principal Investigator, Carolinas Healthcare System
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 17, 2012
||February 9, 2015
||United States: Institutional Review Board
Keywords provided by Carolinas Healthcare System:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 30, 2015
Central Nervous System Diseases
Head Injuries, Closed
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries