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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT03339505
Eligibility Criteria:
Inclusion Criteria:
1. Adult of either gender between 18 and 65 years.
2. Non-penetrating, isolated severe traumatic brain injury
3. GCS \>3 and GCS\<9 on admission or within 48 hours after injury\*
4. Admission to study hospital within 24 hours of injury\*
5. No known history of allergy to egg-protein
6. Planned for intracranial pressure monitoring
7. Absence of bilaterally dilated pupils
8. CT scan with traumatic pathology that is more than an isolated epidural hematoma
* Within 24 hours of injury (for patients with GCS \< 9 on admission) or Within 24 hours of deterioration (among patients deteriorating to GCS \< 9 within 48 hours of injury)
Exclusion Criteria:
1\. No consent 2. Systolic blood pressure below 90 mm Hg post resuscitation 3. Epidural hematoma with no other signs of intra-cranial injury 4. Penetrating injury 5. Non-fulfillment of inclusion criteria after screening and inclusion procedures.
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03339505
Study Brief:
Protocol Section:
NCT03339505