Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage

NCT ID: NCT07246473

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-12-31

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. The trial is conducted at Beijing Tiantan Hospital, with results expected to advance non-invasive ICH treatment options.

Conditions

Intracerebral Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

non-invasive ultrasonic scalpel

Intervention Type: DEVICE

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

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

Group Type: SHAM_COMPARATOR

Sham Comparator

Intervention Type: DEVICE

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

Interventions

non-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.

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruijun Ji

Chief Physician/Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruijun Ji

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital of Capital Medical University

Beijing, , China

Countries

China

Central Contacts

Ruijun Ji

Role: CONTACT

JRJchina@sina.com

86 10 5997 5698

Facility Contacts

Feifei Ma

Role: primary

mafeifei2021@163.com

86 15886460436

Role: backup

JRJchina@sina.com

Other Identifiers

CFH-brain2024-2-2051

Identifier Type: -

Identifier Source: org_study_id