Methylprednisolone for Moderate to Severe Traumatic Brain Injury

Not Applicable

Not yet recruiting

• Conditions: Traumatic Brain Injury
• Interventions: Drug: Methylprednisolone (MP); Drug: Placebo

• Registration Number: NCT07180277
• Lead Sponsor: Zhangjiagang First People's Hospital

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 (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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Study Start: 2025-10-01
• Primary Completion: 2027-10-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 520

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 <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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methylprednisolone	Methylprednisolone (MP)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Distribution of Glasgow Outcome Scale-Extended (GOS-E) scores at 180 days.	180 days

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events after treatment	30 days
All-cause mortality	180 days
Proportion of patients with good neurological outcome (GOS-E 6-8)	180 days