APEX-STROKE CALM-ICH Domain

Inclusion criteria

• Age ≥ 18 years old;
• Symptom onset or last known well≤ 6 hours before randomization;
• Traditional Chinese Medicine syndrome consistent with heat-toxin internal accumulation: at least two of high fever, flushed face, restlessness, dry mouth, or rapid pulse;
• No surgical plan at the time of randomization;
• All corresponding eligibility criteria must be met according to the randomization setting:

• If randomized in the prehospital (ambulance) setting: AI model predicts ICH, FAST score ≥ 2 and GCS ≥ 8;
• If randomized in the emergency department: brain imaging confirms ICH, hematoma volume ≥ 10 mL, NIHSS score ≥ 8, and GCS score≥ 7;
• Provide written informed consent by patient (or approved surrogate)

Exclusion criteria

• Severe comorbid disease likely to interfere with trial treatment, follow-up, or outcome assessment, such as severe heart failure;
• History of epilepsy or seizure-like attack;
• Pregnancy or lactation;
• Subjects meeting any of the following criteria in the corresponding randomization setting shall be excluded:

If randomized in the prehospital (ambulance) setting: blood glucose <2.8 mmol/L; head trauma within the previous 7 days; If randomized in the emergency department: severe hepatic or renal dysfunction, defined as serum creatinine ≥ 2 mg/dL or ALT/AST >3 times the upper limit of normal; secondary cause of hemorrhage, including arteriovenous malformation or other structural abnormality.