Intracerebral Hemorrhage
Conditions
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.
Detailed description
This is a multicenter, randomized, double-blind, controlled trial investigating the use of a 2MHz non-invasive ultrasonic scalpel (ultrasound Doppler flow analyzer, registered as Medical System for Ultrasound Diagnosis) in patients with acute ICH. Eligible participants (n=86 will be randomized 1:1 to either the intervention group (ultrasound + standard medical treatment) or the control group (sham ultrasound + standard treatment). The ultrasound intervention involves daily 20-minute sessions for 7 consecutive days. Primary outcomes include hematoma clearance rates and neurological function improvement, assessed via imaging and clinical scales at multiple time points (baseline, 24±12 hours, 72±12 hours, 7±1days/discharge, 3 months). Safety will be monitored through adverse event tracking, vital signs, and neurological examinations. Ethical approval has been obtained, and all participants will provide informed consent.
Interventions
DEVICEnon-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.
DEVICESham 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
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematoma clearance rate on CT at Day 7±1day after randomization/discharge； | Day 7±1day after randomization/discharge | Hematoma clearance rate is defined as the percentage reduction in intracerebral hematoma volume from baseline to the follow-up CT scan. It is calculated using the formula: \[(Baseline volume - Follow-up volume) / Baseline volume\] x 100%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematoma expansion on CT at 24±12 hours after randomization | 24±12 hours after randomization | A relative increase in hematoma volume ≥ 33%, calculated as: (Follow-up volume - Baseline volume) / Baseline volume ≥ 33%; OR An absolute increase in hematoma volume ≥ 12.5 mL, calculated as: Follow-up volume - Baseline volume ≥ 12.5 mL； |
| Neurological improvement at 24±12 hours after randomization (NIHSS(baseline)- NIHSS(24±12 hours)) | 24±12 hours after randomization | Neurological status as assessed by the National Institutes of Health Stroke Scale (NIHSS) score； The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scale ranges from 0 to 42, where a higher score indicates more severe neurological deficit. |
| Absolute hematoma volume (mL) on CT at 72±12 hours after randomization | 72±12 hours after randomization | — |
| Neurological improvement at 72±12 hours after randomization(NIHSS(baseline)- NIHSS(72±12 hours)) | 72±12 hours after randomization | Neurological status as assessed by the National Institutes of Health Stroke Scale (NIHSS) score； The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scale ranges from 0 to 42, where a higher score indicates more severe neurological deficit. |
| Absolute hematoma volume (mL) on CT at Day 7±1day after randomization/discharge | Day 7±1 day after randomization or discharge | — |
| Absolute perihematomal edema (PHE) volume (mL) on CT at Day 7±1day after randomization/discharge | Day 7±1 day after randomization or discharge | — |
| Neurological improvement at Day 7±1day after randomization/discharge(NIHSS(baseline)- NIHSS( Day 7±1day)) | Day7±1day after randomization or discharge | Neurological status as assessed by the National Institutes of Health Stroke Scale (NIHSS) score； The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scale ranges from 0 to 42, where a higher score indicates more severe neurological deficit. |
| Modified Rankin Scale (mRS) score at 90±7 days after onset | 90±7 days after onset | The modified Rankin Scale (mRS) is a standardized measure of global functional outcome and degree of disability or dependence after a stroke or other neurological disorder. It is a 7-point scale ranging from 0 to 6, with specific criteria for each grade: 0 - No symptoms at all. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. A lower score indicates a better functional outcome. |
Countries
China
Contacts
CONTACTRuijun Ji
PRINCIPAL_INVESTIGATORRuijun Ji
Beijing Tiantan Hospital
Outcome results
None listed