Methylprednisolone for Moderate to Severe Traumatic Brain Injury (NCT07180277) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Methylprednisolone for Moderate to Severe Traumatic Brain Injury
520 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Distribution of Glasgow Outcome Scale-Extended (GOS-E) scores at 180 days.