Methylprednisolone for Moderate to Severe Traumatic Brain Injury
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Methylprednisolone Sodium Succinate Injection in Patients With Moderate to Severe Traumatic Brain Injury
Zhangjiagang First People's Hospital
520 participants
Mar 29, 2026
INTERVENTIONAL
Conditions
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
Plain Language Summary
Simplified for easier understanding
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Interventions
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
Locations(1)
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NCT07180277