Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II (SOITBE II)

This is an interventional treatment trial for Basal Ganglia Hemorrhage focused on measuring basal ganglion hemorrhage, stereotactic surgery, thrombolysis Read More

Inclusion Criteria:

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

Exclusion Criteria:

1. Hematoma involves thalamus, midbrain and other structures.
2. Mass effect or hydrocephalus due to intraventricular hemorrhage.
3. Imaging-based diagnosis of cerebrovascular abnormalities such as ruptured aneurysm, arteriovenous malformation (AVM) and moyamoya disease, hemorrhagic transformation of ischemic infarct and recent recurrence (within 1 year) of cerebral hemorrhage.
4. Manifestation of early stage cerebral herniation such as ipsilateral pupil changes and midline shift exceeding 1 cm.
5. Patients with unstable hematoma or with progression to intracranial hypertension syndrome.
6. Patients with any irreversible coagulopathy or known coagulation disorders; platelet count < 100,000; INR > 1.4.
7. Patients requiring long-term use of anticoagulants.
8. Patients taking dabigatran, apixaban, and/or rivaroxaban (or similar drugs of the same category) before symptoms arise.
9. Bleeding in other sites, including retroperitoneal, gastrointestinal, genitourinary or respiratory tract bleeding; superficial or skin surface bleeding, mainly in the vascular puncture sites or transvenous approaches (e.g. arterial puncture, venous incision, etc.), or the recent surgical sites.
10. Patients who may be pregnant in the near future or are already pregnant.
11. Patients previously enrolled in this study.
12. Patients 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.
13. Patients with an expected survival of less than 6 months.
14. Patients with severe co-morbidity (including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrine, immune and/or hematological disorders) which would affect the outcome assessment.
15. Patients with mechanical heart valve. Biological valves are acceptable.
16. 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.
17. Patients with co-morbidities that would be detrimental if the study begins according to investigators.
18. Lost to follow-up or poor compliance due to various reasons (such as geographical and social factors, drug or alcohol abuse, etc.)
19. Patient or his or her legal guardian/representative is unable or unwilling to give the written informed consent.
20. Patients is in a condition that is not suitable for puncture aspiration plus rt-PA treatment.

Early termination criteria:

1. Serious adverse events related to minimally invasive treatment
2. Interim analysis shows a significant difference in efficacy between the conservative and surgical groups.

Dropout criteria:

Patients who cannot be followed up during the study period are considered dropout. Dropout patients are followed up by telephone, mail or outpatient visits and the reason for the dropout and the last follow-up information should be collected as much as possible.

Elimination criteria:

Patients whose disease-related biological or imaging data are not retained should be discussed for elimination by investigators and statisticians before final analysis.