← Back to all trials
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 \
Source: ClinicalTrials.gov (NCT07180277). StuddyBuddy aggregates publicly available trial information.