Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage
ConditionIntracerebral Hemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 18 to 80 years;
Spontaneous intracerebral hemorrhage (ICH);
Supratentorial ICH;
Hematoma volume <30 mL (calculated using the ABC/2 method);
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
non-invasive ultrasonic scalpel
DeviceOn 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.
Sham Comparator
DeviceOn 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
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Ultrasound Intervention GroupExperimental treatment 1 intervention
Group B: Sham ComparatorSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hematoma clearance rate on CT at 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%.
Time frame
Day 7±1day after randomization/dischargeSecondary outcomes
1
Hematoma expansion on CT at 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；
Time frame
24±12 hours after randomization2
Neurological improvement at 24±12 hours after randomization (NIHSS(baseline)- NIHSS(24±12 hours))
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.
Time frame
24±12 hours after randomization3
Absolute hematoma volume (mL) on CT at 72±12 hours after randomization
Time frame
72±12 hours after randomization4
Neurological improvement at 72±12 hours after randomization(NIHSS(baseline)- NIHSS(72±12 hours))
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.
Time frame
72±12 hours after randomizationSponsors and contacts
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Source ClinicalTrials.gov