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:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT07166393
Eligibility Criteria:
Inclusion Criteria:
1. Male or female between the ages of 18 and 65 years.
2. Body Mass Index between 18 kg/m2 and 35 kg/m2.
3. Females must be surgically sterilized, postmenopausal, or have a negative urine pregnancy test.
4. Moderate to severe TBI: Glasgow Coma Scale (GCS) 3-12.
5. Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG3) criteria
Exclusion Criteria:
1. Persons with known history of adverse reactions to VPA
2. Persons with known history of hepatitis B or C or clinical history of hepatic dysfunction, pancreatitis, or renal insufficiency.
3. Persons with a known history of thrombocytopenia.
4. Persons with platelet count less than 100,000 per microliter of blood.
5. Persons with 2nd or 3rd degree burns of any size and location.
6. Female subjects who are pregnant or lactating.
7. Persons who are currently incarcerated or are in police custody.
8. Persons with inadequate venous access.
9. Treatment cannot start within 120 minutes from the onset of injury
10. Non-survivable injuries in the estimation of the attending trauma surgeon.
11. Interfacility transfers
12. The time of injury is unknown
13. Patients in hemorrhagic shock with a systolic blood pressure of \<90 mmHg on initial evaluation.
14. Persons with a known "do not resuscitate" order prior to randomization
15. Persons with a research "opt out" bracelet
16. Persons who are currently enrolled in another clinical trial.
17. Greater than 90 minutes between the onset of injury and arrival to the hospital
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07166393
Study Brief:
Protocol Section:
NCT07166393