The aim of this trial is to investigate whether neuroendoscopic hematoma evacuation combined with early use of methylprednisolone sodium succinate can improve the efficacy and safety in the treatment with that of simple neuroendoscopic surgery alone for patients with spontaneous basal ganglia intracerebral hemorrhage within 24 hours after the onset.
There is still a lack of the best evidence-based reference for the treatment of basal ganglia intracerebral hemorrhage. The ENRICH trial published in 2024 demonstrated that minimally invasive hematoma evacuation might have a better clinical prognosis than standard medical treatment in patients with spontaneous intracerebral hemorrhage. However, the significant effect of the surgery might be mainly attributed to the intervention in patients with basal ganglia hemorrhage. Besides, simply relying on surgical removal of hematoma may not be sufficient to significantly improve the long-term prognosis of patients. How to effectively control secondary brain injury, reduce cerebral edema and inflammatory response is the key to improving the prognosis of patients with basal ganglia intracerebral hemorrhage. Methylprednisolone sodium succinate can reduce the disruption of the blood-brain barrier and inflammatory response in animal models of intracerebral hemorrhage, and alleviate brain injury. The results of the MARVEL trial released in 2024 showed that methylprednisolone sodium succinate has demonstrated the potential to reduce the incidence of secondary intracerebral hemorrhage (ICH) and mortality in patients with acute ischemic stroke. This study aims to systematically evaluate the efficacy and safety of neuroendoscopic hematoma evacuation combined with the early use of methylprednisolone sodium succinate in patients with basal ganglia intracerebral hemorrhage through a multicenter, prospective, randomized controlled clinical trial. The study will compare the differences in main endpoint indicators such as functional independence, quality of life and survival rate at 3 months and 6 months after surgery between the group receiving surgical treatment combined with methylprednisolone sodium succinate and the group receiving surgical treatment alone, so as to explore the impact of different treatment strategies on the prognosis of patients with basal ganglia intracerebral hemorrhage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
For patients with spontaneous intracerebral hemorrhage within 24 hours after the onset of the disease, only simple neuroendoscopic evacuation of hematoma will be performed
For patients with spontaneous intracerebral hemorrhage within 24 hours after the onset of the disease, they will be treated with the combination of neuroendoscopic hematoma evacuation and sodium methylprednisolone succinate. Administer sodium methylprednisolone succinate for injection by intravenous injection 6 hours after the onset of the disease. Specific administration: Intravenous injection at a dosage of 2 mg/kg, once daily, for three consecutive days.
The Affiliated Hospital of Southwest Medical University
Luzhou, China, China
Modified Rankin scale score (mRS)
disability level. The presence of impairments determines the transitions from mRS score 0 to mRS score 1 (symptoms) and mRS score 5 to mRS score 6 (death).
Time frame: 180 days
The mortality rate
evaluate death rate of the two treatment groups
Time frame: 30 days
Proportion of patients non-disabled (Modified Rankin scale score (mRS) 0 to 1)
excellent outcome
Time frame: 180 days
Proportion of patients functionally independent (Modified Rankin scale score (mRS) 0 to 2)
functional independence
Time frame: 180 days
Proportion of patients ambulatory or bodily needs-capable or better (Modified Rankin scale score (mRS) 0 to 3)
ambulatory or bodily needs-capable or better
Time frame: 180 days
Change in National Institute of Health stroke scale (NIHSS) score between baseline and 7~10d or at discharge
neurological changes. The scoring range is from 0 to 42 points. The higher the score is, the more severe the degree of neurological impairment in patients will be.
Time frame: 7~10 days or at discharge
Change in Glasgow Coma Scale(GCS) between baseline and 7~10d or at discharge
evaluate the state of consciousness. The scoring range is from 3 to 15 points. The lower the score is, the worse the patient's conscious state will be.
Time frame: 7~10 days or at discharge
Improvement in residual hematoma volume between baseline and 7d or at discharge
Time frame: 7~10 days or at discharge
Barthel Index Score(BI)
evaluate the Activities of Daily Living.The scoring range is from 0 to 100 points. The lower the score is, the poorer the patient's activities of daily living ability will be.
Time frame: 180 days
European Quality Five Dimensions Five Level scale (EQ-5D-5L)
Health-related quality of life. The scoring range is from 5 to 25 points. The higher the score is, the poorer the patient's health-related quality of life will be.
Time frame: 180 days
Mortality within 7 days randomly or at discharge
evaluate death rate of the two treatment groups
Time frame: 7days or at discharge
symptomatic intracranial rebleeding, asymptomatic intracranial rebleeding and intracranial infection
Time frame: within 30 days after randomized
symptomatic intracranial rebleeding, asymptomatic intracranial rebleeding and intracranial infection
Time frame: within 180 days after randomized
severe adverse events
evaluate complications and any adverse events
Time frame: within 180 days after randomization
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