Actively Recruiting
Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage
Led by Beijing Tiantan Hospital · Updated on 2026-04-17
86
Participants Needed
3
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Diagnosed with spontaneous intracerebral hemorrhage
- Hemorrhage located in the supratentorial region
- Hematoma volume less than 30 mL calculated by ABC/2 method
- Glasgow Coma Scale score greater than 9 at randomization
- Time from onset to randomization is between 48 and 72 hours
- Patient or legal representative provides informed consent
You will not qualify if you...
- Intracerebral hemorrhage caused by cerebral aneurysm, vascular malformation, brain tumor, venous sinus thrombosis, ischemic stroke hemorrhagic transformation, head trauma, anticoagulation therapy, or blood disorders
- Hemorrhage located in the infratentorial region
- Hemorrhage mainly in the ventricular system
- Symptoms indicating brain herniation such as worsening consciousness, absent pupillary reflexes, or bilateral pyramidal signs
- Severe heart dysfunction classified as NYHA Class III or IV
- High-risk chronic arrhythmias including sick sinus syndrome, advanced atrioventricular block, or syncope without pacemaker
- Severe liver impairment with ALT or AST over twice the upper limit of normal
- Severe kidney impairment with serum creatinine over 1.5 times the upper limit of normal
- History of severe asthma or chronic obstructive pulmonary disease
- History of blood clotting or bleeding disorders
- Low white blood cell count below 2 x 10^9/L or low platelet count below 100 x 10^9/L
- Scheduled surgical intervention before first study treatment dose
- Pre-stroke modified Rankin Scale score greater than 2
- Other severe diseases with expected life expectancy under 1 year
- Psychiatric illness, cognitive impairment, or emotional disorders preventing study understanding or follow-up
- Pregnant or breastfeeding women
- Participation in another clinical trial within the past 3 months or currently enrolled in another trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Wannan Medical University
Wuhu, Anhui, China
Not Yet Recruiting
2
Beijing Fengtai You'anmen Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
Beijing Tiantan Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
R
Ruijun Ji
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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