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Recruiting NCT07180277

Methylprednisolone for Moderate to Severe Traumatic Brain Injury

Conditions: Traumatic Brain Injury

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 520
Sponsor: Zhangjiagang First People's Hospital

Location: Zhangjiagang First People's Hospital Suzhou Jiangsu

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 Criteria

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 \22.2 mmol/L. * Shock at admission (systolic blood pressure \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07180277). StuddyBuddy aggregates publicly available trial information.