Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage

Exclusion Criteria20

• . Brainstem or cerebellar hemorrhage; or thalamic hemorrhage with significant midbrain shift accompanied by third nerve palsy or unreactive dilated pupils.
• . Irreversible brainstem dysfunction (bilateral fixed, dilated pupils and decerebrate posturing).
• . Secondary ICH caused by: head trauma, arteriovenous malformation (AVM), moyamoya disease, intracranial aneurysm, coagulation disorders (hereditary or acquired hemorrhagic diathesis, hemophilia, coagulation factor deficiency, leukemia, etc.), hemorrhagic transformation of cerebral infarction, or tumor; multiple intracranial hemorrhages, subarachnoid hemorrhage (SAH), primary intraventricular hemorrhage, drug-induced hemorrhagic stroke, subdural hemorrhage, epidural hemorrhage.
• . Significant abnormalities in the following laboratory parameters:(1)International normalized ratio (INR) > 1.4; any irreversible coagulopathy or known coagulation disorder that cannot be corrected with procoagulants to maintain INR ≤ 1.4. (2) Severe hepatic insufficiency: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 times the upper limit of normal (ULN). (3) Severe renal insufficiency: estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m². (4)Hemoglobin < 90 g/L.5）Platelet count < 100 × 10⁹/L.
• . History of malignancy, autoimmune diseases (including but not limited to systemic lupus erythematosus, systemic vasculitis), hemorrhagic diathesis (including various hereditary and acquired bleeding disorders), malignant arrhythmias, cardiac insufficiency (B-type natriuretic peptide \[BNP\] ≥ 1000 pg/mL or left ventricular ejection fraction \[LVEF\] ≤ 40%), acute myocardial infarction, acute or severe infectious diseases (e.g., intracranial infection, severe pneumonia, sepsis), or any other severe concurrent illness that may exacerbate the condition or interfere with efficacy assessment.
• . Known high risk of thromboembolism, including: presence of a mechanical heart valve prosthesis, history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. (Note: Atrial fibrillation without mitral stenosis is permitted).
• . Myocardial infarction within 30 days prior to randomization.
• .Use of anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban) within 1 week prior to symptom onset.
• . History of internal bleeding (e.g., gastrointestinal bleeding, genitourinary bleeding, retroperitoneal bleeding) within 3 months prior to randomization.
• . Major surgery or vascular puncture (e.g., venesection, arterial puncture) within 3 months prior to randomization.
• . History of significant head trauma or severe stroke within 3 months prior to randomization.
• . History of intracerebral hemorrhage within 1 year prior to randomization.
• . Indications for craniotomy: (1) Progressive impairment of consciousness; (2)Preoperative signs of brain herniation (e.g., foramen magnum herniation, tentorial herniation) posing a life-threatening condition.
• . Intraventricular hemorrhage (IVH) or ICH with rupture into the ventricle causing intraventricular cast formation and/or hydrocephalus anticipated to require external ventricular drainage (EVD).
• . Patient or family requests craniotomy or neuroendoscopic surgery for hematoma evacuation.
• . Pre-randomization decision by patient/family for Do-Not-Resuscitate (DNR) or Do-Not-Intubate (DNI) orders regarding life-sustaining measures.
• . Known hypersensitivity or intolerance to TNK.
• . Pregnancy (positive urine pregnancy test) in women of childbearing potential.
• . Concurrent participation in another investigational drug or device study.
• . History of drug or alcohol abuse/dependence, severe dementia, or psychiatric disorder prior to randomization, anticipated to result in poor compliance and inability to complete follow-up.