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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT05097261
Eligibility Criteria:
Inclusion Criteria:
* Traumatic brain injury patients
* Age \>= 18 years
* Admitted to the ICU
* Within 72 hours after admission to the initial hospital:
* ICP monitoring in place (parenchymal probe, ventricular catheter, or both)
* Requiring sedation
Exclusion Criteria:
* Known pregnancy and/or lactation
* Imminent or actual brain death upon inclusion
* Allergy or intolerance to the study medication
* Pre-existing neurocognitive disorders, pre-existing congenital or non-congenital brain dysfunction.
* Inability to obtain informed consent
* Inclusion in an interventional randomised controlled trial of which the PI indicates that co-inclusion specifically in the BIKe study is prohibited.
* Therapy restriction code upon inclusion.
* Porphyria
* Glaucoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05097261
Study Brief:
Protocol Section:
NCT05097261