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 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT00178659
Eligibility Criteria:
Inclusion Criteria:
* 14-65 years old
* Non-penetrating brain injury
* ICP monitor or
* Healthy volunteer or
The orthopedic injury cohort will include patients admitted to the ED able to provide informed consent with the following:
1. Fracture confirmed radiographically
2. No head trauma
3. No other known inflammatory process or infection
4. No history of neurological or psychiatric disorders or alcohol or drug dependency.
or The mild TBI patients will be defined as those experiencing,
1. Non-penetrating head trauma manifesting one or more of the following:
* Loss of consciousness
* Post-traumatic amnesia
* Altered mental status
* Focal neurologic deficits, seizure
2. GCS\> 12
3. No abnormalities on CT other than contusion
4. No operative Lesions
5. Length of hospital stay \< 48 hrs
6. No other known inflammatory process or infection
7. No history of neurological or psychiatric disorders or alcohol or drug dependency
Exclusion Criteria:
* Inability to obtain informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
65 Years
Study:
NCT00178659
Study Brief:
Protocol Section:
NCT00178659