Acute spontaneous supratentorial intracerebral hemorrhage
Conditions
Interventions
Standard Internal Medicine Treatment Group:Standard Internal Medicine Treatment
Trial group:stereotactic minimally invasive drainage for intracerebral hemorrhage combined with TNK, single TNK dose 0.5 mg/time
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 80 years, any gender; 2. Clinically confirmed acute spontaneous supratentorial intracerebral hemorrhage (ICH), with diagnostic CT completed within 24 hours of symptom onset; 3. CT-confirmed supratentorial ICH with hematoma volume calculated by ABC/2 method between 25 mL and 60 mL (inclusive); 4. National Institutes of Health Stroke Scale (NIHSS) score >= 6; 5. Glasgow Coma Scale (GCS) score between 9 and 14 (inclusive); 6. Pre-stroke modified Rankin Scale (mRS) score <= 1; 8. Good compliance, with written informed consent provided by the patient and/or legal guardian, and ability to adhere to the scheduled follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Brainstem or cerebellar hemorrhage; or thalamic hemorrhage with significant midbrain shift accompanied by third nerve palsy or unreactive dilated pupils; 2. Irreversible brainstem dysfunction (bilateral fixed, dilated pupils and decerebrate posturing); 3. Secondary ICH caused by: head trauma, arteriovenous malformation (AVM), cerebral amyloid angiopathy (CAA), 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; 4. 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 = 3 times the upper limit of normal (ULN). 3)Severe renal insufficiency: estimated glomerular filtration rate (eGFR) = 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; 6. 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); 7. Myocardial infarction within 30 days prior to randomization; 8. Use of anticoagulants (e.g., warfarin, dabigatran, rivaroxaban, apixaban) within 1 week prior to symptom onset; 9. History of internal bleeding (e.g., gastrointestinal bleeding, genitourinary bleeding, retroperitoneal bleeding) within 3 months prior to randomization; 10. Major surgery or vascular puncture (e.g., venesection, arterial puncture) within 3 months prior to randomization; 11. History of significant head trauma or severe stroke within 3 months prior to randomization; 12. History of intracerebral hemorrhage within 1 year prior to randomization; 13. Indications for craniotomy: (1) Progressive impairment of consciousness; (2) Preoperative signs of brain herniation (e.g., foramen magnum herniation, uncal herniation) posing a life-threatening condition; 14. Intraventricular hemorrhage (IVH) or ICH with rupture into the ventricle causing intraventricular cast formation and/or hydrocephalus anticipated to require external ventricular drainage (EVD); 15. atient or family requests craniotomy or neuroendoscopic surgery for hematoma evacuation; 16. Pre-randomization decision by patient/family for Do-Not-Resuscitate (DNR) or Do-Not-Intubate (DNI) orders regarding life-sustaining measures; 17. Known
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality within 30 days post-randomization.;The proportions of mRS scores of 0-3 points at 180 day after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in NIHSS score from baseline to Day 7 after randomization (or at early discharge if earlier);Proportion of subjects with mRS score 0-1;Overall incidence of Adverse Events (AEs) within 180 days post-randomization;Proportion of subjects with mRS score 0-2;All-cause mortality;Hematoma clearance rate at 7 days post-randomization;UW-mRS;Intracranial infection rate within 30 days post-randomization;Residual hematoma volume on Day 7 post-randomization;Symptomatic rebleeding rate within 30 days post-randomization;EQ-5D-5L questionnaire score;Overall incidence of Serious Adverse Events (SAEs) within 180 days post-randomization;Extended Glasgow Outcome Scale (eGOS) score (favorable: 4-8; unfavorable: 1-3);Ordinal analyses of modified Rankin Scale;ICU length of stay (from onset to the end of the follow-up period); | — |
Countries
China
Contacts
Public ContactZhouping Tang
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed