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

Korábbi kezelés

• 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.

Más betegség

• 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.
• Patients with genetic or acquired bleeding tendencies, coagulation disorders such as deficiency of coagulation factors.
• Myocardial infarction occurred within the recent 30 days.
• Known to have a high embolism risk, including patients with mechanical heart valves implanted in the body, 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.

Laborértékek

• 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.

Egyéb

• 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.

• 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.
• The National Institutes of Health Stroke Scale (NIHSS) score should be ≥ 6 points at the time of randomization.
• The Glasgow Coma Scale (GCS) score should range from 5 to 14 points at the time of randomization.
• The modified Rankin Scale (mRS) score before the onset of the disease should be 0 - 1 points.
• The patient and their legal representative should sign a written informed consent form.