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.
Aged between 18 and 80 years old.
Diagnosed with spontaneous intracerebral hemorrhage (ICH) through cranial CT scan, with the bleeding site located in the basal ganglia region.
Calculate the hematoma volume based on the cranial CT scan. The volume should range from 30 to 80 ml, and the shift of the mid - line structure at the pineal gland level should be less than 3 mm. The formula for calculating the hematoma volume is V (cm³)=A * B * C * 1/2, where A represents the longest diameter (cm) of the largest hematoma layer in the horizontal position of the plain CT scan, B is the widest diameter (cm) of the hematoma perpendicular to A on this plane, and C is the thickness (cm) of the hematoma shown in the CT images.
The time from the onset of the disease to randomization should be within 24 hours. If the actual onset time is unclear, the onset time will be regarded as the time when the subject was last confirmed to be in good health.
Hemorrhage in other locations (such as hemorrhage in infratentorial regions like the lobes, thalamus, brainstem, or cerebellum).
Hemorrhage caused by other reasons (for example, hemorrhage due to aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhagic transformation of large-area cerebral infarction, hemorrhage caused by amyloid angiopathy, hemorrhage resulting from coagulation disorders) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-area cerebral infarction, amyloid angiopathy, severe coagulation disorders.
Patients with intraventricular hemorrhage or those with intracerebral hemorrhage (ICH) breaking into the ventricles and considered to require external ventricular drainage.
A history of any parenchymal brain hemorrhage or other intracranial subarachnoid, subdural, or epidural hemorrhage and a history of relevant surgeries within the recent 30 days.
Parallel
Simple neuroendoscopic hematoma evacuation
Procedure/SurgeryFor patients with spontaneous intracerebral hemorrhage within 24 hours after the onset of the disease, only simple neuroendoscopic evacuation of hematoma will be performed
Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinate
Combination productFor 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.
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).
The mortality rate
evaluate death rate of the two treatment groups
Proportion of patients non-disabled (Modified Rankin scale score (mRS) 0 to 1)
excellent outcome
Proportion of patients functionally independent (Modified Rankin scale score (mRS) 0 to 2)
functional independence
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
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.
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Yong Jiang
Lead sponsor
The Affiliated Hospital Of Southwest Medical University
Sponsor institution
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