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Methylprednisolone for Moderate to Severe Traumatic Brain Injury

RecruitingPhase 4Ages 18 Years - 65 YearsAllZhangjiagang First People's Hospital
NCT07180277 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Placebo
  • Methylprednisolone (MP)
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Where

1 site
Zhangjiagang First People's Hospital
Suzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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