Methylprednisolone for Moderate to Severe Traumatic Brain Injury

Condition(s) studied

Investigational drug(s) / intervention(s)

Placebo: 2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days

Methylprednisolone (MP): 2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days

Study 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.

Eligibility

Primary outcome measure(s)

• Distribution of Glasgow Outcome Scale-Extended (GOS-E) scores at 180 days. — 180 days

Trial sites (1)

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