Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation

Inclusion criteria

• Diagnosis of spontaneous basal ganglia hemorrhage by imaging (CT, CTA, etc.) with a volume < 30 mL calculated by ABC/2 formula and Glasgow Coma Scale score ≥ 9.
• With dysfunction such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength ≤ grade 3 or NIHSS score ≥ 15 points.
• Hematoma stability shown by a CT scan at least 6 hours after the diagnostic CT (hematoma volume increase < 5 ml by ABC/2 formula)
• Diagnostic CT scan should be obtained within 24 hours after the onset of symptoms. Cases with unclear onset time should be excluded.
• Randomization within 72 hours after diagnostic CT.
• Surgery should be performed within 72 hours after onset.
• SBP <180 mmHg maintained for 6 hours prior to randomization.
• Age between 18-70 years old.
• mRS score ≤ 1 in past medical history.
• Patients who are suitable and willing to be randomized to "puncture aspiration + urokinase" or conservative medical treatment.

Exclusion criteria

• Hematoma involves other structures such as the thalamus and midbrain.
• Mass effect or hydrocephalus due to intraventricular hemorrhage.
• Imaging-based diagnosis of cerebrovascular abnormalities such as ruptured aneurysm, arteriovenous malformation (AVM) and moyamoya disease as well as hemorrhagic transformation of ischemic infarct and recent recurrence (within 1 year) of cerebral hemorrhage.
• Manifestation of early stage cerebral herniation such as ipsilateral pupil changes and midline shift exceeding 1 cm.
• Patients with unsteady hematoma or with progression to intracranial hypertension syndrome.
• Patients with any irreversible coagulopathy or known coagulation disorders; platelet count <100,000; INR > 1.4.
• Patients requiring long-term use of anticoagulants.
• Patients taking dabigatran, apixaban and/or rivaroxaban (or similar drugs of the same category) before symptoms arise.
• Bleeding in other sites, including retroperitoneal, gastrointestinal, genitourinary or respiratory tract bleeding; superficial or skin surface bleeding mainly occurring in the vascular puncture site or transvenous approach (eg. arterial puncture, venous incision, etc. ) or in the recent surgical site.
• May be pregnant in the near future or already pregnant.
• Previously enrolled in this study.
• Participating in other interventional medical research or clinical trials at the same time.

Patients enrolled in observational, natural history and/or epidemiological studies (without intervention) are eligible for this trial.

• Patients with an expected survival of less than 6 months.
• Patients with severe co-morbidity (including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrine, immune and/or hematological disorders) which may affect the outcome assessment.
• Patients with mechanical heart valve. Biological valves are acceptable.
• Patients with risk of embolism (including a history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis or subacute bacterial endocarditis). Atrial fibrillation without mitral stenosis is acceptable.
• Investigators believe co-morbidities would be detrimental to the patient when the study begins.
• Patients difficult to follow up or with poor compliance due to various reasons (such as geographical and social factors, drug or alcohol abuse, etc.)
• Patient or his or her legal guardian/representative is unable or unwilling to give the written informed consent.
• Patients is in a condition that is not suitable for "puncture aspiration + urokinase" treatment.