Methylprednisolone for moderate to severe traumatic brain injury
Official 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
Run by Zhangjiagang First People's Hospital · NCT07180277 · Data updated 2026-11-12
This trial tests whether a 5-day course of methylprednisolone helps adults with moderate to severe traumatic brain injury recover better than placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 520 (estimated) |
| Sponsor | Zhangjiagang First People's Hospital Academic / other |
| Locations | 1 site (Suzhou, Jiangsu) |
| Status | Recruiting |
| Started | March 29, 2026 |
| Main results expected | January 31, 2029 |
| Study ends | July 31, 2029 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT07180277 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with moderate-to-severe TBI (GCS 4–12 on admission) and evidence of cerebral contusion on CT, to be treated within 12 hours of injury.
✕Probably not a fit
Patients who do not respond to steroid therapy, who have contraindications to corticosteroids, or who do not meet the timing or imaging criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study enrolls adults aged 18–65 with moderate-to-severe TBI and starts the drug within 12 hours of injury. Participants are randomly assigned to receive either methylprednisolone or a placebo for 5 days in addition to standard care, with monitoring during hospitalization and follow-up visits. The trial will assess long-term neurological outcomes, 6-month survival, and safety related to steroid use. Imaging and neuro-exams guide ongoing assessments, and informed consent is required before enrollment.
Why it matters
Potential benefit: If successful, treatment could improve long-term neurological recovery and reduce mortality after traumatic brain injury.
How similar studies have gone: Previous research in similar contexts has produced mixed results, making this trial important to determine efficacy and safety.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age18-65 years. * Patients with moderate-to-severe traumatic brain injury whose Glasgow Coma Scale (GCS) score at admission is4-12. * Study drug must be initiated within12 hours after injury. * Imaging (CT) demonstrates cerebral contusion, or cerebral contusion with intracerebral hematoma. * Written informed consent obtained from the subject or legally authorized representative. Exclusion Criteria: * Known hypersensitivity to corticosteroids or any contraindication to their use. * History of diabetes mellitus requiring pharmacological treatment, or capillary blood glucose\<2.8 mmol/L or \>22.2 mmol/L. * Shock at admission (systolic blood pressure\<90 mmHg for more than30 minutes). * Pregnant or lactating women. * Patients with systemic infectious diseases. * Patients with a confirmed diagnosis of peptic ulcer. * Patients with a confirmed diagnosis of systemic autoimmune diseases. * Participation in another clinical trial within the past3 months. * Any condition that, in the investigator's opinion, renders the patient unsuitable for this study.
Where it's running
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Zhangjiagang First People's Hospital
Suzhou, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Xiaobo Qian
- Email: 776730288@qq.com
- Phone: +86 13616248318
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.