Mild Traumatic Brain Injury Registry

Brain Injury, Traumatic Clinical Trial

— mTBI  

Official title:

Mild Traumatic Brain Injury Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688869
• Other study ID #: 04-12-03A
• Status: Completed
• Start date: April 2012
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Brain Injury, Traumatic
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury.		6 months