NCT07246473 Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage
| NCT ID | NCT07246473 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Intracerebral Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2025-12-12 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 86 participants in total. It began in 2025-12-12 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Ruijun Ji
PRINCIPAL INVESTIGATOR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT07246473 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Intracerebral Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07246473 currently recruiting?
Yes, NCT07246473 is actively recruiting participants. Contact the research team at JRJchina@sina.com for enrollment information.
Where is the NCT07246473 trial being conducted?
This trial is being conducted at Wuhu, China, Beijing, China, Beijing, China.
Who is sponsoring the NCT07246473 clinical trial?
NCT07246473 is sponsored by Beijing Tiantan Hospital. The principal investigator is Ruijun Ji at Beijing Tiantan Hospital. The trial plans to enroll 86 participants.