Traumatic Brain Injury
Conditions
Keywords
Methylprednisolone, Traumatic Brain Injury
Brief summary
The goal of this clinical trial is to learn if standard-dose methylprednisolone sodium succinate can improve neurological recovery and safety in adults with moderate to severe traumatic brain injury (TBI). The main questions it aims to answer are: 1. Does adding a 5-day course of methylprednisolone improve overall long-term neurological outcome compared with placebo? 2. Does methylprednisolone reduce 6-month mortality or increase the proportion of patients with good neurological recovery? 3. What medical problems do participants experience when receiving methylprednisolone? Researchers will compare methylprednisolone sodium succinate (2 mg/kg/day intravenously for 5 days) with a matching placebo to see if the steroid improves outcomes beyond standard TBI care. Participants will: 1. Receive either methylprednisolone or placebo once daily for 5 days, added to guideline-directed standard care. 2. Undergo CT scans and neuro-examinations during hospitalization. 3. Return for follow-up visits at 1 month and 6 months after injury for neurological assessments, safety checks, and questionnaires.
Interventions
DRUGPlacebo
2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days
2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days
Sponsors
Zhangjiagang First People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years. * Patients with moderate-to-severe traumatic brain injury whose Glasgow Coma Scale (GCS) score at admission is 4-12. * Study drug must be initiated within 12 hours after injury. * Imaging (CT) demonstrates cerebral contusion, or cerebral contusion with intracerebral hematoma. * Written informed consent obtained from the subject or legally authorised representative.
Exclusion criteria
* Known hypersensitivity to corticosteroids or any contraindication to their use. * History of diabetes mellitus, or capillary blood glucose \<2.8 mmol/L or \>22.2 mmol/L. * Shock at admission (systolic blood pressure \<90 mmHg for more than 30 minutes). * Pregnant or lactating women. * Participation in another clinical trial within the past 3 months. * Any condition that, in the investigator's opinion, renders the patient unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distribution of Glasgow Outcome Scale-Extended (GOS-E) scores at 180 days. | 180 days |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality | 180 days |
| Proportion of patients with good neurological outcome (GOS-E 6-8) | 180 days |
| Incidence of adverse events after treatment | 30 days |
Outcome results
None listed