Spontaneous cerebral hemorrhage
Conditions
Interventions
Hematoma puncture group:Minimally invasive hematoma aspiration drainage combined with urokinase injection
Drug conserved group:Symptomatic treatment with drugs
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 18-80; 2) ICH in the basal ganglia was diagnosed by CT examination of the head (bleeding mainly from the caudate nucleus, lentiform nucleus, clavate nucleus or amygdala); 3) Based on CT examination of the head, the volume of hematoma was calculated to be 20-40ml, and the midline structure was shifted horizontally in the pineal gland < 3mm; The calculation formula of hematoma volume V (cm3) =A*B*C*1/2, where A is the longest diameter (cm) of the largest level of hematoma in the horizontal CT scan, B is the widest diameter (cm) of the hematoma in the plane perpendicular to A, and C is the thickness (cm) of the hematoma in the CT film. 4) The time from onset to randomization is within 48 hours; 5) GCS score 4-14 points during randomization; 6) NIHSS score =6 points during randomization; 7) Muscle strength of unilateral limbs on the symptomatic side is grade 0-3; 8) mRS0-1 score before onset; 9) Systolic blood pressure was controlled below 180mmHg before randomization; 10) Written informed consent signed by the patient and his legal representative.
Exclusion criteria
Exclusion criteria: 1) Bleeding in other areas (such as the thalamus, brain stem, or cerebellum); 2) Bleeding caused by other causes (such as aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhage transformation of massive cerebral infarction, hemorrhage caused by amyloidosis, hemorrhage caused by coagulation disorder) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, massive cerebral infarction, amyloidosis, severe coagulation disorder; 3) Recent history of cerebral hemorrhage ( 1.4; 11) Long-term anticoagulant and antiplatelet therapy is expected; 12) There is a history of internal bleeding, such as digestive tract bleeding, urogenital system bleeding, respiratory tract bleeding is not completely controlled; 13) Myocardial infarction within the last 30 days; 14) Known high risk of embolism, including 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; 15) Severe liver function damage, ALT > 3 times the upper limit of normal, or AST > 3 times the upper limit of normal. Severe renal insufficiency, glomerular filtration rate < 30ml/min/1.73m2; 16) Hypertension that could not be effectively controlled by active antihypertensive therapy before randomization (systolic blood pressure was still greater than 180mmHg); 17) Patients with Alzheimer's disease or mental illness are unable to complete the follow-up plan as required; 18) Combined with any serious diseases that may be assessed to interfere with the test results: including diseases of the respiratory system, circulatory system, digestive system, genitourinary system, endocrine system, immune system and blood system; 19) Those who currently have drug or alcohol abuse or dependence and are expected to have poor compliance and difficulty in completing follow-up; 20) Allergic to urokinase or surgery-related drugs and instruments; 21) Pregnant or lactating women, or those planning to become pregnant within one year; 22) Life expectancy of < 12 months due to advanced stage of any disease; 23) Are participating in other clinical trials or have been included in this trial in the previous stage; 24) The patient or his legal guardian is not willing to sign a written informed consent.(YNMT)·
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS; | — |
Secondary
| Measure | Time frame |
|---|---|
| volume of hematoma;NIHSS ; | — |
Countries
China
Contacts
Public ContactHAO XU
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Outcome results
None listed