Status:
NOT_YET_RECRUITING
Methylprednisolone for Moderate to Severe Traumatic Brain Injury
Lead Sponsor:
Zhangjiagang First People's Hospital
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 (...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT07180277
Start Date
October 1 2025
End Date
March 1 2028
Last Update
September 18 2025
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