RECRUITING Phase 4 ClinicalTrials.gov

Methylprednisolone for Moderate to Severe Traumatic Brain Injury

Sponsor: Zhangjiagang First People's Hospital • ClinicalTrials.gov ID: NCT07180277

Registry updated: 2026-09-22

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Description

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

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

Eligibility criteria

Inclusion Criteria: * Age18-65 years. * Patients with moderate-to-severe traumatic brain injury whose Glasgow Coma Scale (GCS) score at admission is4-12. * Study drug must be initiated within12 hours after injury. * Imaging (CT) demonstrates cerebral contusion, or cerebral contusion with intracerebral hematoma. * Written informed consent obtained from the subject or legally authorized representative. Exclusion Criteria: * Known hypersensitivity to corticosteroids or any contraindication to their use. * History of diabetes mellitus requiring pharmacological treatment, or capillary blood glucose\<2.8 mmol/L or \>22.2 mmol/L. * Shock at admission (systolic blood pressure\<90 mmHg for more than30 minutes). * Pregnant or lactating women. * Patients with systemic infectious diseases. * Patients with a confirmed diagnosis of peptic ulcer. * Patients with a confirmed diagnosis of systemic autoimmune diseases. * Participation in another clinical trial within the past3 months. * Any condition that, in the investigator's opinion, renders the patient unsuitable for this study.

Conditions

Traumatic Brain Injury

Locations

Zhangjiagang First People's Hospital — Suzhou, Jiangsu, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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