Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT01688869
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT01688869
Study Brief:
Protocol Section:
NCT01688869