Non-invasive ultrasound to speed hematoma clearance after intracerebral hemorrhage

Study on the Safety and Efficacy of Non-Invasive Transcranial Doppler Ultrasound in Promoting Hematoma Clearance for Intracerebral Hemorrhage

This trial tests whether daily non-invasive ultrasound sessions added to standard care help people with supratentorial intracerebral hemorrhage clear the bleed faster and improve recovery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 3 sites (Wuhu, Anhui and 2 other locations)
• Trial ID: NCT07246473 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–80 years with spontaneous supratentorial ICH, hematoma volume <30 mL, GCS >9, and who can be randomized 48–72 hours after symptom onset are ideal candidates.

Not a fit: Patients with infratentorial or primarily intraventricular hemorrhage, hemorrhages due to other identified causes (e.g., aneurysm, tumor, trauma), large hematoma volumes, severe cardiac dysfunction, or those outside the 48–72 hour window are unlikely to benefit.

Why it matters

Potential benefit: If successful, the device could accelerate hematoma clearance and reduce disability after intracerebral hemorrhage.

How similar studies have performed: Ultrasound-enhanced thrombolysis has produced mixed results in ischemic stroke, and using non-invasive ultrasound specifically to speed hematoma clearance in ICH is relatively novel with limited prior clinical data.

Eligibility criteria

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 this trial is running

Wuhu, Anhui and 2 other locations

• The First Affiliated Hospital of Wannan Medical University — Wuhu, Anhui, China (Not_yet_recruiting)
• Beijing Fengtai You'anmen Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Tiantan Hospital of Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Ruijun Ji — Beijing Tiantan Hospital
• Study coordinator: Ruijun Ji

Conditions Intracerebral Hemorrhage