Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Treatment of Lobar Intracerebral Hemorrhage at the Early Stage.

Ki vehet részt

• 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
• The National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 points at the time of randomization
• The Glasgow Coma Scale (GCS) score is between 5 and 14 points at the time of randomization
• The modified Rankin Scale (mRS) score is 0-1 points prior to the onset of the disease
• The patient and his or her legal representative sign the written informed consent form

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• Expected to require long-term anticoagulation and antiplatelet therapy
• A history of previous internal hemorrhage, with risks of gastrointestinal bleeding (such as gastrointestinal ulcers), genitourinary bleeding, or respiratory tract bleeding that has not been fully controlled
• Currently participating in other clinical trials or having been previously enrolled in this trial
• 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
• Patients with genetic or acquired bleeding tendencies, coagulation disorders such as deficiency of coagulation factors
• Myocardial infarction occurring within the past 30 days
• Known to have a high embolism risk, including patients with mechanical heart valves implanted in vivo, a history of left heart thrombus, mitral stenosis accompanied by atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is eligible
• Patients with Alzheimer's disease or mental disorders who are unable to complete the follow-up plan as required
• Complicated by any severe diseases that, upon evaluation, may interfere with the trial results, including diseases of the respiratory system, circulatory system, digestive system, genitourinary system, endocrine system, immune system, and hematopoietic system, etc
• Allergic to drugs or devices related to the operation
• In the terminal stage of any disease with an expected lifespan of less than 6 months
• Platelet count < 75 × 10⁹/L
• Undergoing anticoagulant drug treatment with warfarin, dabigatran, or rivaroxaban, etc. within one week before enrollment, and having an international normalized ratio (INR) > 1.4
• Severe liver function impairment, with alanine aminotransferase (ALT) > 3 times the upper limit of the normal range, or aspartate aminotransferase (AST) > 3 times the upper limit of the normal range. Severe renal insufficiency, with a glomerular filtration rate < 30 ml/min/1.73 m²
• Pregnant or lactating women, or those planning to become pregnant within one year
• The patient or his/her legal guardian is unwilling to sign the written informed consent form