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

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.

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.