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:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT03659006
Eligibility Criteria:
Inclusion Criteria:
1. patient ≥ 18 years old at the time of inclusion
2. Written and informed consent obtained from the family / proxy
3. Patient hospitalized in neuro-ICU following severe TBI with GCS ≤ 8 at admission
4. Intubated / ventilated patient scheduled for external ventricular bypass within 24 hours of hospitalization
5. Absence of contraindications to perform an MRI
6. Patient affiliated to a social security scheme (free State medical aid excluded)
Exclusion Criteria:
1. Patient under protection of the law (guardianship or tutorship)
2. TBI of ballistic origin
3. Pregnant woman
4. Pre-existing cerebral disease that can bias the MRI scan evaluation
5. Contraindications to the MRI (pace maker, medical device incompatible with MRI, metal plates, ...)
6. Patient with severe impairment of vital and / or life-threatening function with disability prior TBI
7. Neurological antecedent susceptible to interfere with clinical evolution at one year
8. Severe cardiogenic shock
9. Severe respiratory impairment
10. Extra-brain injuries involving immediate life-threatening
11. Hemoglobin level below 9g / dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03659006
Study Brief:
Protocol Section:
NCT03659006