spontaneous supratentorial intracerebral hemorrhage
Conditions
Interventions
experimental group:Stereotactic intracranial hematoma puncture and drainage combined with urokinase
Sponsors
The Second Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. CT examination of the head diagnosed ICH in the basal ganglia region (the hemorrhage was mainly from caudate nucleus, pterygoid nucleus, platygoid nucleus or amygdala); 3. the hematoma volume was calculated according to the head CT examination, 20-40ml, and the midline structure was horizontally displaced in the pineal gland = 6 at the time of randomization; 8. mrs0-1 before onset; 9. Symptom lateral limb muscle strength 0-3; 10. the systolic pressure was controlled below 180mmHg before randomization; 11. written informed consent signed by the patient and his legal representative.
Exclusion criteria
Exclusion criteria: 1. bleeding from other sites (e.g., subtentorial sites such as thalamus, brainstem or cerebellum); 2. other causes of bleeding (such as aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhage of large area cerebral infarction, beta amyloid degeneration disease caused by bleeding, blood coagulation dysfunction caused by bleeding) or merger of aneurysm, arteriovenous malformation, brain trauma, brain tumors, large area cerebral infarction, beta amyloid degeneration disease, serious blood coagulation disorders; 3. a recent history of cerebral hemorrhage ( 1.4; 11. long-term anticoagulation and antiplatelet therapy is expected; 12. previous history of internal bleeding, such as gastrointestinal bleeding, genitourinary bleeding, respiratory bleeding is not fully controlled; 13. myocardial infarction within 30 days; 14. known risks of high embolization include patients with mechanical heart valve implantation, a history of left ventricular thrombosis, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is appropriate; 15. severe liver function damage, ALT > 3 times the normal upper limit, or AST > 3 times the normal upper limit. Severe renal insufficiency, glomerular filtration rate < 30ml/min/1.73m2; 16. hypertension that could not be effectively controlled after active antihypertensive treatment before randomization (systolic blood pressure was still greater than 180mmHg); 17. patients with alzheimer's disease or mental illness cannot complete the follow-up plan as required; 18. merger of any serious diseases that are assessed as likely to interfere with the test results, including diseases of the respiratory, circulatory, digestive, urogenital, endocrine, immune and blood systems; 19. patients with current drug or alcohol abuse or dependence are expected to have poor compliance and difficult to complete follow-up; 20. allergic to urokinase or surgically related drugs and instruments; 21. pregnant or lactating women, or planning to become pregnant within one year; 22. life expectancy < 12 months due to any advanced stage of disease; 23. is participating in other clinical trials or has been included in this trial in the early stage; 24. the patient or his legal guardian is unwilling to sign the written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS score at 180 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| NIHSS at 5-7 day;Residual hematoma volume after surgery;The integrity and continuity of the corticospinal tract at the lesion at 5-7 days;Barthel Index at 180 day;EQ-5D at 180 day;symptomatic intracranial rebleeding rate, intracranial infection rate, mortality rate within 30 days;Symptomatic rebleeding, asymptomatic intracerebral hemorrhage and mortality within 180 days;Incidence of other serious adverse events (including pneumonia, respiratory failure, renal failure, stress ulcer, circulatory failure, secondary epilepsy, sepsis, deep venous thrombosis, etc); | — |
Countries
China
Contacts
Public ContactQingwu Yang
The Second Affiliated Hospital of the Army Medical University
Outcome results
None listed