Non-invasive ultrasound to speed hematoma clearance after intracerebral hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, sham-controlled trial will enroll 86 adults with spontaneous supratentorial intracerebral hemorrhage and hematoma volume under 30 mL, randomizing them 1:1 to a 2 MHz non-invasive ultrasound device plus standard medical treatment or sham ultrasound plus standard treatment. The active intervention is a 20-minute ultrasound session delivered daily for seven consecutive days starting 48–72 hours after symptom onset. Primary endpoints are hematoma clearance on imaging and neurological function measured at baseline, 24±12 hours, 72±12 hours, around day 7/discharge, and at 3 months, with continuous safety monitoring via adverse event reporting and neurological exams. The trial is conducted at multiple centers in China and requires informed consent from participants or their legal representatives.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Fengtai You'anmen Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Tiantan Hospital of Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Wannan Medical University
  Wuhu, Anhui, China Not yet recruiting

Study contacts

• Principal investigator: Ruijun Ji — Beijing Tiantan Hospital
• Study coordinator: Ruijun Ji
• Email: JRJchina@sina.com
• Phone: 86 10 5997 5698

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.