Intracerebral Hemorrhage
Conditions
Interventions
Group2:Minimally invasive hematoma puncture and drainage combined with low dose teneplase (0.5mg/ time) liquefaction treatment
Group1:Minimally invasive hematoma puncture and drainage combined with medium dose teneplase (0.25mg/ time) liquefaction treatment
Group3:Minimally invasive hematoma puncture and drainage combined with relatively high dose teneplase (0.75mg/ time) liquefaction treatment
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. age18-80; 2. spontaneous supratentorial ICH(6h—3day after ictus); 3. hematoma volume >25ml comfirmed by CT scan (ABC2 method); 4. Blood biochemical indexes meet the following conditions: (1) Good coagulation function, international standardized ratio (INR) 50mL/min; (4) Hemoglobin > 90g/L; (5) Neutrophil absolute value (ANC)>=1.5×10^9/L, lymphocyte absolute value (ANC) >=0.4×10^9/L, platelet count >=80×10^9/L, albumin > 25g/L. 5. mRS=5; 7. Systolic blood pressure was controlled below 180mmHg before surgery; 8. Good compliance, signed informed consent form by myself and/or legal guardian, and able to receive follow-up according to the prescribed time.
Exclusion criteria
Exclusion criteria: 1. Brain stem, cerebellar hemorrhage, thalamic hemorrhage with significant midbrain displacement with third nerve palsy or pupil dilation did not respond; 2. Irreversible impairment of brain stem function (bilateral fixation, pupil dilation, and extensor movement posture); 3. Secondary cerebral hemorrhage caused by brain injury, arteriovenous malformation, amyloidosis, moyamoya disease, intracranial aneurysm, coagulation dysfunction (hereditary or acquired bleeding constitution, hemophilia, coagulation factor deficiency, leukemia, etc.), hemorrhage transformation after cerebral infarction or tumor; Multiple intracranial hemorrhage, subarachnoid hemorrhage, primary ventricular hemorrhage, drug-induced hemorrhagic stroke; 4. The following blood biochemical indicators are significantly abnormal: (1) International standardized ratio (INR) > 1.4, any irreversible coagulation disorder or known coagulation disorder can not be maintained with coagulants INR=3 times the upper limit of normal; (3) Severe renal insufficiency, glomerular filtration rate =1000pg/mL or left ventricular ejection fraction <= 40%), acute myocardial infarction, acute or severe Severe infectious diseases (such as intracranial infection, severe pneumonia, sepsis, etc.) and other serious diseases that may aggravate the condition and affect the evaluation of curative effect; 6. A known high risk of embolism includes patients with mechanical heart valve implantation, history of left heart thrombosis, mitral stenosis with atrial fibrillation, acute pericarditis or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is suitable; 7. any co-existing serious diseases that seriously affect prognosis, including diseases of the liver, kidney, gastrointestinal, respiratory, cardiovascular, endocrine, immune and hematological systems, and neoplasms; 8. Myocardial infarction in the last 30 days; 9. Use of warfarin, dabigatran, rivaroxaban, Apoxaban and other anticoagulants within 1 week before onset; 10. Patients with a history of internal bleeding within 3 months, such as gastrointestinal bleeding, urogenital bleeding, and retroperitoneal bleeding; 11. Major surgery, vascular puncture (such as venotomy, arterial puncture) within 3 months; 12. severe head trauma or severe stroke within 3 months; 13. a history of cerebral hemorrhage within 1 year; 14. signs of craniotomy: (1) progressive consciousness disorder; (2) Patients with preoperatively existing cerebral hernia, foramen occipitalis magnus hernia, temporal sulcus hernia related signs threatening life; 15. Ventricular hemorrhage or intracerebral hemorrhage into the ventricle resulting in ventricular cast, hydrocephalus expected to require external ventricular drainage; 16. Patients requiring craniotomy or neuroendoscopic treatment to remove hematoma; 17. Patients not expected to survive to the end of the 30-day follow-up, or the patient refusing cardiopulmonary resuscitation or tracheal intubation; 18. allergy or intole
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality within 30 days;Hematoma clearance rate after 1 week; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptomatic rebleeding rate within 72 hours;Incidence of surgery-related deaths within 7 days;Incidence of intracranial infection within 30 days;Asymptomatic rebleeding rate within 30 days;Overall incidence of Serious Adverse events (SAE) within 30 days (including symptomatic rebleeding, pneumonia, respiratory failure, circulatory failure, renal failure, stress ulcer, secondary epilepsy;After the first teneplase treatment, a visit was required to review the volume of cerebral hematoma calculated by brain CT;NIHSS score, GCS score, mRS Score after 30 days; | — |
Countries
China
Contacts
Public ContactZhouping Tang
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed