Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage (NESICH)

This is an interventional treatment trial for Intracerebral Hemorrhage Basal Ganglia (Diagnosis) focused on measuring Intracerebral hemorrhage, NeuroEndoscopic Surgery Read More

Inclusion Criteria:

1. Patient age ≥ 18 and ≤ 80.
2. Symptoms less than 24 hours prior to diagnostic CT scan. For an unknown time of onset, use the time the patient was last known to be well.
3. Spontaneous supratentorial deep ICH ≥25 ml (deep location involving the basal ganglia, thalamus, internal capsule, or deep periventricular white matter).
4. The stability of the hematoma was determined by CT angiogram (CTA) examination. If the spot sign is positive, repeat CT scan at least 6 hours after diagnostic CT (dCT) showing clot stability (growth <5 ml). (If the clot volume measured on this stability CT scan increases by 5 ml or more, a second stability determination is allowed by repeat CT scan at least 6 hours later, until the randomization time window is closed )
5. Glasgow Coma Scale（GCS） ≥ 5 and ≤ 14, National Institutes of Health Stroke Scale（NIHSS） ≥ 6.
6. Historical Rankin score of 0 or 1.
7. Systolic blood pressure（SBP） <180 mmHg sustained for six hours recorded closest to the time of randomisation.
8. Randomization must be done within 24 hours after dCT.
9. Written informed consent must be obtained from patients or their relatives.

Exclusion Criteria:

1. Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, mass or tumor, trauma, haemorrhagic conversion of an ischemic infarct, diagnosed with radiographic imaging.
2. Infratentorial hemorrhage, primary thalamic ICH, lobar ICH, primary Intraventricular hemorrhage.
3. Hematoma with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions.
4. Patients with life-threatening mass effect caused by hematoma (e.g., CT showed midline deviation of more than 1cm, cisterna ambient compression disappeared), or patients whose condition was considered to be unstable and not suitable for inclusion.
5. Multiple hemorrhages. Defined as 2 or more separate hematomas in multiple location (lobar, deep, brain stem, cerebellum, subdural hemorrhage, subarachnoid hemorrhage).
6. Intraventricular hemorrhage（IVH) is visually estimated to involve >50% of either of the lateral ventricles.
7. Subjects requiring long-term anti-coagulation are excluded.
8. Use of dabigatran, apixaban, and/or rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset.
9. Any irreversible coagulopathy or known clotting disorder.
10. Platelet count <1,000,000;International Normalized Ratio (INR) >1.4.
11. Inability to sustain INR ≤1.4 using short- and long-acting procoagulants (such as but not limited to NovoSeven, Fresh frozen plasma（FFP）, and/or vitamin K).
12. Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing).
13. Recurrence of a recent (<1 year) hemorrhage.
14. History of surgery or any parenchymal or other intracranial arachnoid hemorrhage, subdural or extradural hemorrhage within the past 30 days.
15. There was a history of uncompleted haemorrhage in the past, such as gastrointestinal bleeding, urogenital bleeding and respiratory bleeding.
16. History of myocardial infarction within the past 30 days.
17. Known risk for embolisation, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is permitted.
18. Patients with severe hepatic impairment, such as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceed 3 times upper limit of normal.
19. Patients with severe renal insufficiency (estimated glomerular filtration rate <=30ml / min/1.73 m2) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.
20. Before randomization, Systolic blood pressure(SBP) could not be effectively controlled below 180 mmHg after active antihypertensive therapy.
21. patients with mental illness or cognitive impairment limiting their ability to complete follow-up plan.
22. Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrine, immunologic, and hematologic disease.
23. Active drug or alcohol use or dependence that, or poor compliance due to other reasons, in the opinion of the site investigator, would interfere with adherence to study requirements.
24. Allergy/sensitivity to surgery-related drugs (anesthesia, antibiotic), surgical instruments, contrast agent.
25. Pregnant or nursing mothers and female expecting to become pregnant within one year.
26. End-stage any disease or known life-expectancy of less than 6 months.
27. Any other conditions that the investigator believes it would pose a significant hazard to the subject if the investigational therapy were initiated.
28. Participation in a concurrent interventional medical investigation or clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving an intervention are eligible