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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT03281759
Eligibility Criteria:
Inclusion Criteria:
1\) Patient victims of Traumatic Brain Injury with Glasgow Coma Scale ≤8 on admission:
1. Head CT scan showing diffuse axonal lesion.
2. CT scan without focal surgical lesions (Marshall I and II) and no signs of intracranial hypertension.
3. Transcranial Doppler and optic nerve sheath US with no signs of intracranial hypertension.
4. Admission less than 8 hours of trauma.
Exclusion Criteria:
1. History of drug or narcotic abuse.
2. Emergence of surgical lesions or signs of intracranial hypertension in followup CTs.
3. Transcranial Doppler or optic nerve sheath US presenting signs of intracranial hypertension.
4. Psychiatric disorders.
5. Injury severity score ≥3, according to the Abbreviated Injury Scale
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03281759
Study Brief:
Protocol Section:
NCT03281759