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NCT07246473

Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-01

Completion Date

2027-12-31

Last Updated

2025-11-24

Healthy Volunteers

Conditions

Intracerebral Hemorrhage

Interventions

DEVICE

non-invasive ultrasonic scalpel

On the basis of best medical management, 2 MHz non-invasive ultrasonic scalpel was used for intervention within 48-72 hours after the occurrence of intracerebral hemorrhage, 20min/ day, and continued for 7 days.

DEVICE

Sham Comparator

On the basis of best medical management, a sham non-invasive ultrasonic scalpel (simulating real treatment with zero energy output) was applied within 48-72 hours after the occurrence of intracerebral hemorrhage, 20 min/day for 7 consecutive days

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.

Locations (1)

Beijing Tiantan Hospital of Capital Medical University

Beijing, China