Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage

NCT07246473 | Recruiting DMC

• 1 other identifier: CFH-brain2024-2-2051
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 3

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.

Conditions

Intracerebral Hemorrhage

Outcome Measures

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%.

  Day 7±1day after randomization/discharge

Secondary Outcomes (8)

• Hematoma expansion on CT at 24±12 hours after randomization

  24±12 hours after randomization

• Neurological improvement at 24±12 hours after randomization (NIHSS(baseline)- NIHSS(24±12 hours))

  24±12 hours after randomization

• 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

• Absolute hematoma volume (mL) on CT at Day 7±1day after randomization/discharge

  Day 7±1 day after randomization or discharge

Study Arms (2)

Ultrasound Intervention Group

EXPERIMENTAL

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.

Device: non-invasive ultrasonic scalpel

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

Device: Sham Comparator

Interventions

non-invasive ultrasonic scalpel 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.

Ultrasound Intervention Group

Sham Comparator 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

Sham Comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (3)

The First Affiliated Hospital of Wannan Medical University

Wuhu, Anhui, China

NOT YET RECRUITING

Beijing Fengtai You'anmen Hospital

Beijing, Beijing Municipality, China

RECRUITING

Beijing Tiantan Hospital of Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruijun Ji

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruijun Ji

CONTACT

86 10 5997 5698; JRJchina@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician/Professor

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: November 24, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 17, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)