Methylprednisolone for Moderate to Severe Traumatic Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2028-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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methylprednisolone

Group Type EXPERIMENTAL

Methylprednisolone (MP)

Intervention Type DRUG

2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days

Interventions

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Placebo

2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days

Intervention Type DRUG

Methylprednisolone (MP)

2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No