Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Intracerebral Hemorrhage

In brief

Intracerebral hemorrhage (ICH) is one of the stroke subtypes with the highest global rates of disability and mortality, accounting for 15%-20% of all strokes. Currently, there is a lack of evidence-based interventions for ICH, with treatment primarily relying on supportive care. There is an urgent clinical need to explore new strategies and technologies. The investigators hypothesize that for ICH patients, best medical treatment combined with a non-invasive ultrasonic scalpel (ultrasound Doppler flow analyzer) may be superior to best medical treatment alone. The primary objective of this study is to determine the safety and efficacy of the non-invasive ultrasonic scalpel in promoting hematoma clearance in ICH patients.

Key facts

Study ID: NCT07246473
Run by: Beijing Tiantan Hospital
People needed: 86
Starts: 2025-12-12
Expected to finish: 2027-12-31
Last updated by the study team: 2026-04-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

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

Full record on ClinicalTrials.gov

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