Clinical Trial

Methylprednisolone for Moderate to Severe Traumatic Brain Injury

Study acronym: ESM-TBI Trail
Not Yet Recruiting Phase 4
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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.
Trial Details
NCT Number NCT07180277
Lead Sponsor Zhangjiagang First People's Hospital
Conditions Traumatic Brain Injury
Enrollment 520 participants
Start Date 2025-10-01
Primary Completion 2027-10-01 (estimated)
Study Completion 2028-03-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-18