NCT07180277 Methylprednisolone for Moderate to Severe Traumatic Brain Injury
| NCT ID | NCT07180277 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Zhangjiagang First People's Hospital |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 520 participants |
| Start Date | 2026-03-29 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 520 participants in total. It began in 2026-03-29 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07180277 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07180277 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07180277 currently recruiting?
Yes, NCT07180277 is actively recruiting participants. Contact the research team at 776730288@qq.com for enrollment information.
Where is the NCT07180277 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT07180277 clinical trial?
NCT07180277 is sponsored by Zhangjiagang First People's Hospital. The trial plans to enroll 520 participants.