Traumatic brain injury. Diffuse traumatic brain injury
Conditions
Interventions
Intervention 1: Intervention group: Intervention: Riluzole at a dose of 50 mg, manufactured by Sobhan Darou Pharmaceutical Company, a product of Iran, will be administered during hospitalization in th
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 18 or older Confirmed diagnosis of severe TBI (GCS = 8) at the time of admission ICU admission within 24 hours of initial injury Obtaining informed consent to participate in the study from the patient or the patient's legal guardian. The patient's hemodynamic (in terms of blood pressure and heart rate) and respiratory stability before participating in the study
Exclusion criteria
Exclusion criteria: Patients with pre-existing neurological or cognitive disorders that could impair the assessment of cognitive function Pregnant or breastfeeding women Known hypersensitivity to riluzole or its derivatives Current use of medications that interact with riluzole Inability to obtain informed consent from the patient or the patient's legal guardian. Presence of other serious medical conditions that would interfere with the administration of riluzole or the evaluation of outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improving the cognitive status of patients. Timepoint: The first day and two weeks after taking the drug. Method of measurement: functional independence measure, montreal cognitive assessment , mini-mental state examination, glasgow outcome scale-Extended , ct scan , magnetic resonance imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improving quality of life. Timepoint: At the beginning of the study and at discharge. Method of measurement: Glasgow Outcome Scale - Expanded. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyyed Hamidreza Shojaei
Mazandaran University of Medical Sciences
Outcome results
None listed