Cerebral hemorrhage
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age range: 18-80 years old; 2. Spontaneous cerebral parenchymal hemorrhage; 3. Supertentorial intracerebral hemorrhage (ICH); 4. Hematoma volume is less than 30ml (calculated by ABC/2 method); 5. Glasgow Coma Scale >= 9 points at random; 6. The time from onset to randomization is = 8 points; 8. Informed consent from patients and/or their families.
Exclusion criteria
Exclusion criteria: 1. Secondary cerebral hemorrhage, such as secondary to cerebral aneurysms, cerebral arteriovenous malformations, brain tumors, cerebral venous thrombosis, antithrombotic therapy (antiplatelet, anticoagulant therapy, etc.), hemorrhagic transformation after cerebral infarction, hematological diseases, etc. 2. Clinical symptoms and signs of the patient indicate signs of cerebral herniation, such as progressive decrease in consciousness level, weakened or absent pupil reflex to light; 3. There are already obvious signs of pneumonia, such as fever, persistent cough or cough with yellow purulent sputum, and imaging examinations (chest X-rays or chest CT) indicating signs of pneumonia; Two consecutive measurements of body temperature >= 37.5 °C, or one measurement of body temperature >= 38.0 °C; 4. A history of severe cardiovascular disease, meeting any of the following criteria: 1) heart failure (New York Heart Association functional class >= III); 2) Unstable angina pectoris within 3 months; 3) Any supraventricular arrhythmia or ventricular arrhythmia that requires treatment; 4) Researchers believe that clinically significant QTc interval prolongation (reference range for males>450ms, females>470ms) (note: QTc interval must be calculated according to Fridericia's criteria); 5) Complete atrioventricular block and left and right bundle branch block requiring treatment; 6) Acute myocardial infarction or interventional treatment within the past month; High risk of chronic arrhythmia, such as sinus syndrome, second or third degree atrioventricular block, bradycardia related syncope without pacemaker, etc; 5. Diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc; Or ALT or AST>3 times the upper limit of normal values; 6. Severe renal insufficiency: such as patients undergoing dialysis, or diagnosed with severe active kidney disease, or creatinine clearance rate<50mL/min; 7. Patients with other serious illnesses whose life expectancy is less than one year; 8. Patients who plan to undergo surgical intervention treatment before the first administration, including but not limited to hematoma evacuation surgery (including minimally invasive and conventional surgery), decompressive craniectomy, hematoma aspiration, and ventricular puncture external drainage; 9. Unable to understand the research procedure and/or complete follow-up due to factors such as mental illness, cognitive impairment, emotional disorders, etc. 10. Pregnant or lactating women; 11. Participated in other clinical studies within 3 months or is currently participating in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of pneumonia ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinary tract infection or infections of other systems;NIHSS10d-NIHSS basline ;Length of Stay;direct medical costs;short-term prognosis; | — |
Countries
China
Contacts
Beijing Tiantan Hospital, Capital Medical University