Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage

This is a multicenter, randomized, double-blind, controlled trial investigating the use of a 2MHz non-invasive ultrasonic scalpel (ultrasound Doppler flow analyzer, registered as Medical System for Ultrasound Diagnosis) in patients with acute ICH. Eligible participants (n=86 will be randomized 1:1 to either the intervention group (ultrasound + standard medical treatment) or the control group (sham ultrasound + standard treatment). The ultrasound intervention involves daily 20-minute sessions for 7 consecutive days. Primary outcomes include hematoma clearance rates and neurological function improvement, assessed via imaging and clinical scales at multiple time points (baseline, 24±12 hours, 72±12 hours, 7±1days/discharge, 3 months). Safety will be monitored through adverse event tracking, vital signs, and neurological examinations. Ethical approval has been obtained, and all participants will provide informed consent.

Inclusion criteria

• Age 18 to 80 years;
• Spontaneous intracerebral hemorrhage (ICH);
• Supratentorial ICH;
• Hematoma volume <30 mL (calculated using the ABC/2 method);
• Glasgow Coma Scale (GCS) score >9 at randomization;
• Time from onset to randomization: 48-72 hours;
• Patient and/or legal representative provides informed consent.

Exclusion criteria

• Intracerebral hemorrhage attributed to other causes (e.g., cerebral aneurysm, cerebrovascular malformation, brain tumor, cerebral venous sinus thrombosis, hemorrhagic transformation of ischemic stroke, head trauma, anticoagulation therapy, hematologic disorders).
• Hemorrhage located in the infratentorial region.
• Hemorrhage confined primarily to the ventricular system.
• Clinical signs or symptoms suggestive of brain herniation (e.g., progressive decline in level of consciousness, diminished or absent pupillary light reflexes, bilateral pyramidal signs).
• Severe cardiac dysfunction (NYHA Class III or IV).
• High-risk chronic arrhythmias (e.g., sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia-related syncope without pacemaker implantation).
• Severe hepatic impairment defined as ALT >2x ULN or AST >2x ULN (ULN = Upper Limit of Normal).
• Severe renal impairment defined as serum creatinine >1.5x ULN.
• History of severe asthma or chronic obstructive pulmonary disease (COPD).
• History of coagulopathy or systemic bleeding disorder.
• Leukopenia (<2 × 10⁹/L) or thrombocytopenia (<100 × 10⁹/L).
• Patients scheduled for surgical intervention (including, but not limited to, hematoma evacuation [minimally invasive or conventional], decompressive craniectomy, hematoma aspiration, or external ventricular drainage) prior to the first dose of study treatment.
• Pre-stroke modified Rankin Scale (mRS) score >2.
• Presence of other severe disease resulting in a life expectancy of less than 1 year.
• Inability to understand the study procedures and/or complete follow-up due to psychiatric illness, cognitive impairment, or emotional disorders.
• Women who are pregnant or lactating.
• Participation in another clinical trial within the past 3 months or current participation in another clinical trial.