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Methylprednisolone for Moderate to Severe Traumatic Brain Injury

ConditionTraumatic Brain Injury
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZhangjiagang First People's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

520 Participants
are divided into 2 treatment groups
Group A: methylprednisoloneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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 5-8)

Time frame
180 days
3

Incidence of adverse events after treatment

Time frame
30 days

Other outcomes

1

CT Measurement of Cerebral Edema Volume

Time frame
From enrollment to 7 days after the end of medication
2

Mini-Mental State Examination (MMSE)

Time frame
180 days
3

EQ-5D-VAS Scores

Time frame
180 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhangjiagang First People's Hospital

Lead sponsor

Source ClinicalTrials.gov
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