Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT04991233
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18-80 years old;
2. Cerebellar hemorrhage was confirmed by computed tomography (CT) scans;
3. The hematoma was \> 3 cm in diameter or the hematoma volume was \> 10ml or the hemorrhage is associated with brainstem compression or hydrocephalus;
4. The randomization can be conducted within 24 hours;
5. GCS score at randomization was 5-14;
6. mRS was 0-1 before onset;
7. The systolic pressure was controlled below 180 mmHg before randomization;
8. Informed consent was obtained from the patient and his legal representative.
Exclusion Criteria:
1. Coexistent intracranial bleeding from other sites;
2. Brain herniation before randomization;
3. Bleeding caused by other reasons such as aneurysm, arteriovenous malformation, trauma, and tumor; hemorrhage secondary to large cerebral infarction, beta-amyloid degeneration disease, or coagulation dysfunction; coexistent aneurysm, arteriovenous malformation, brain trauma, brain tumors, large area cerebral infarction, beta-amyloid degeneration disease, or serious blood coagulation disorders;
4. A history of cerebral hemorrhage within 1 year;
5. A history of intracranial surgery or hemorrhagic disease (intracerebral hemorrhage, subarachnoid hemorrhage, subdural or epidural hemorrhage) within the last 30 days;
6. Hemoglobin \< 100g/L, hematocrit \< 25%, platelet count \<100\*10\^9/L;
7. Warfarin, dabigatran, rivaroxaban, and other anticoagulant drugs were given within one week before enrollment, and the INR was \> 1.4;
8. Aspirin, clopidogrel, ticagrelor, and other antiplatelet drugs were given within one week before enrollment, and the inhibition rate of AA-dependent pathway \> 50%，inhibition rate of ADP-dependent pathway \> 30%;
9. Long-term anticoagulation and antiplatelet therapy is needed;
10. A history of internal bleeding that is not completely controlled, such as gastrointestinal bleeding, genitourinary bleeding, respiratory bleeding;
11. Myocardial infarction within 30 days;
12. Patients with high risks of embolization (a history of mechanical heart valve implantation, left ventricular thrombosis, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis); atrial fibrillation without mitral stenosis is acceptable;
13. Severely impaired liver function (ALT \> 3 times the normal upper limit, or AST \> 3 times the normal upper limit); severely impaired renal function (glomerular filtration rate \< 30ml/min/1.73m2);
14. Hypertension could not be effectively controlled before randomization (systolic blood pressure ≥ 180 mmHg);
15. Patients cannot complete the follow-up due to Alzheimer's disease or mental illness;
16. Coexistent serious diseases of the respiratory, circulatory, digestive, urogenital, endocrine, immune, and blood systems that are likely to interfere with the results;
17. Patients with current drug/alcohol abuse or dependence, or expected to have poor compliance and difficult to complete the follow-up;
18. Allergic to the drugs or instruments used in surgery;
19. Patients with surgery contraindications, or the other factors that may preclude implementation of the study protocol;
20. Pregnant or lactating women;
21. Life expectancy \< 12 months due to any advanced stage of disease;
22. Patient is participating in other clinical trials;
23. The legal guardian of the patient is unwilling to sign the written informed consent;
24. Assessed unsuitable for inclusion by investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04991233
Study Brief:
Protocol Section:
NCT04991233