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
Qualifiers
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
Treatments tested in this trial
- non-invasive ultrasonic scalpel
- Sham Comparator
Treatment groups
86 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov