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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT05263167
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged between 18-80 years old;
2. Spontaneous ICH confirmed by cranial CT;
3. Time from onset to randomization within 24 hours;
4. Superatentorial ICH;
5. Hematoma volume between 10-30 ml (calculated using ABC/2 method);
6. Glasgow coma scale (GCS) \> 9 on admission;
7. informed and consent.
Exclusion Criteria:
1. Suspected secondary cause of ICH (e.g. aneurysm, vascular malformation, neoplasia, cerebral venous thrombosis, hemorrhagic transformation of recent ischemic stroke, thrombolysis or endovascular treatment, anticoagulation, et al);
2. ICH secondary to traumaļ¼
3. Primary intraventricular hemorrhage (IVH);
4. Signs of herniation, such as progressive decline in consciousness, decreased or disappearance of pupillary light reflection, bilateral pyramidal tract signs, etc;
5. Other serious, advanced or terminal illness such that life expectancy is less than one year (e.g. advanced metastatic cancer);
6. Severe cardiac insufficiency (NYHA class III or IV);
7. High-risk arrhythmia, such as sick sinus syndrome, second or third degree atrioventricular block, bradycardia-related syncope without a pacemaker, etc;
8. Severe liver insufficiency; severe liver insufficiency is defined as ALT \> 2 times the upper limit of normal or AST greater than 2 times the upper limit of normal;
9. Severe renal insufficiency: Severe renal insufficiency is defined as creatinine greater than 1.5 times the upper limit of normal;
10. History of severe asthma or chronic obstructive pulmonary disease (COPD);
11. History of coagulopathy or systemic bleeding;
12. A thrombocyte count below \<100 x 10\^9/L or leukocytosis \< 2 x 10\^9/L on admission;
13. Patients who plan to undergo surgical intervention before the first administration, including but not limited to hematoma removal (including minimally invasive and conventional surgery), decompressive craniectomy, hematoma aspiration, and ventricular puncture external drainage;
14. Patients with preexisting disability of a modified Rankin Scale (mRS) score greater than 2 prior to ICH;
15. Unable to understand the research procedures and/or complete follow-up due to mental illness, cognitive impairment, affective disorder, etc;
16. Women of childbearing potential, pregnant, or breastfeeding at randomization;
17. Contraindication to sodium aescinateļ¼
18. Participate in other clinical studies within 3 months or are participating in other clinical studies.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05263167
Study Brief:
Protocol Section:
NCT05263167