Traumatic Brain Injury
Conditions
Interventions
Control Group:Placebo [2 mg/kg administered intravenously in 100 mL normal saline (maximum dose not exceeding 160 mg), once daily for 5 consecutive days].
Experimental Group:Methylprednisolone Sodium Succinate for Injection [2 mg/kg administered intravenously in 100 mL normal saline (maximum dose not exceeding 160 mg), once daily for 5 consecutive days]
Sponsors
The First People's Hospital of Zhangjiagang City
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-65 years, regardless of gender 2.Patients with moderate to severe traumatic brain injury (TBI) presenting with a Glasgow Coma Scale (GCS) score of 4-12 on admission 3.Received medication within 12 hours after injury 4.Imaging (CT) findings of cerebral contusion or cerebral contusion accompanied by intracerebral hematoma 5.Signed informed consent form
Exclusion criteria
Exclusion criteria: 1.Patients with known hypersensitivity to glucocorticoids or contraindications to glucocorticoid use. 2.History of diabetes mellitus, or capillary blood glucose 22.2 mmol/L. 3.Patients presenting with shock on admission (systolic blood pressure persistently < 90 mmHg for 30 minutes). 4.Pregnant or lactating women. 5.Systemic infectious diseases. 6.Patients with a confirmed diagnosis of peptic ulcer. 7.Patients with a confirmed diagnosis of systemic autoimmune diseases. 8.Participation in other clinical trials within the past 3 months. 9.Patients with other severe concomitant diseases that, in the investigator's judgment, may endanger 10.patient safety or affect the patient's ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in the Distribution of the Extended Glasgow Outcome Scale (GOS-E) at 180 Days; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-Cause Mortality at 180 Days;180d GOS-E 5-8 Score Proportion (Favorable Prognosis);30d Post-Treatment Adverse Event Incidence; | — |
Countries
China
Contacts
Public ContactGao Rong
The First People's Hospital of Zhangjiagang City
Outcome results
None listed