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Study on the Safety and Efficacy of Non-Invasive Transcranial Doppler Ultrasound in Promoting Hematoma Clearance for Intracerebral Hemorrhage

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Fengtai You'anmen Hospital
RECRUITING
Beijing
Beijing Tiantan Hospital of Capital Medical University
RECRUITING
Beijing
The First Affiliated Hospital of Wannan Medical University
NOT_YET_RECRUITING
Wuhu
Contact Information
Primary
Ruijun Ji
JRJchina@sina.com
86 10 5997 5698
Time Frame
Start Date: 2025-12-12
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 86
Treatments
Experimental: Ultrasound Intervention Group
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.
Sham_comparator: Sham 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
Related Therapeutic Areas
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov