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NCT Number: NCT07180277

Methylprednisolone for Moderate to Severe Traumatic Brain Injury

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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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

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

Methylprednisolone (MP)

Drug

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

Primary outcomes

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

    Time frame: 180 days

Secondary outcomes

  1. All-cause mortality

    Time frame: 180 days

  2. Proportion of patients with good neurological outcome (GOS-E 6-8)

    Time frame: 180 days

  3. Incidence of adverse events after treatment

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Zhangjiagang First People's Hospital

Other

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Methylprednisolone Sodium Succinate Injection in Patients With Moderate to Severe Traumatic Brain Injury

Acronym: ESM-TBI Trail

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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