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 lobar intracerebral hemorrhage within 24 hours after the onset.
The age ranges from 18 to 80 years old.
Diagnosed as spontaneous intracerebral hemorrhage (ICH) by cranial computed tomography (CT) examination, with the bleeding site located in the lobar region of the brain.
Calculate the hematoma volume according to the cranial CT examination, which should be within the range of 30 to 80 ml, and the shift of the midline structure at the level of the pineal gland is less than 3 mm. The formula for calculating the hematoma volume V (cubic centimeters) is V = A × B × C × 1/2. Here, A represents the longest diameter (in centimeters) of the largest hematoma layer on the horizontal position of the plain CT scan, B refers to the widest diameter (in centimeters) of the hematoma perpendicular to A on this plane, and C stands for the thickness (in centimeters) of the hematoma shown on the CT film.
The time interval from the onset of the disease to randomization is within 24 hours. In case the actual onset time is not clear, the onset time will be regarded as the time when the subject was last confirmed to be in good health.
Hemorrhage in other locations (e.g., hemorrhage in infratentorial sites such as the basal ganglia, thalamus, brainstem, or cerebellum).
Hemorrhage due to other causes (e.g., hemorrhage resulting from aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhagic transformation of large-area cerebral infarction, hemorrhage caused by amyloid angiopathy, hemorrhage due to coagulation disorders) or complicated by aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-area cerebral infarction, amyloid angiopathy, severe coagulation disorders.
Patients with intraventricular hemorrhage or those in whom intracerebral hemorrhage (ICH) has ruptured into the ventricles and who are 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 past 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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