Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07246473

Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage

Led by Beijing Tiantan Hospital · Updated on 2026-04-17

86

Participants Needed

3

Research Sites

107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 80 years
  • Diagnosed with spontaneous intracerebral hemorrhage
  • Hemorrhage located in the supratentorial region
  • Hematoma volume less than 30 mL calculated by ABC/2 method
  • Glasgow Coma Scale score greater than 9 at randomization
  • Time from onset to randomization is between 48 and 72 hours
  • Patient or legal representative provides informed consent
Not Eligible

You will not qualify if you...

  • Intracerebral hemorrhage caused by cerebral aneurysm, vascular malformation, brain tumor, venous sinus thrombosis, ischemic stroke hemorrhagic transformation, head trauma, anticoagulation therapy, or blood disorders
  • Hemorrhage located in the infratentorial region
  • Hemorrhage mainly in the ventricular system
  • Symptoms indicating brain herniation such as worsening consciousness, absent pupillary reflexes, or bilateral pyramidal signs
  • Severe heart dysfunction classified as NYHA Class III or IV
  • High-risk chronic arrhythmias including sick sinus syndrome, advanced atrioventricular block, or syncope without pacemaker
  • Severe liver impairment with ALT or AST over twice the upper limit of normal
  • Severe kidney impairment with serum creatinine over 1.5 times the upper limit of normal
  • History of severe asthma or chronic obstructive pulmonary disease
  • History of blood clotting or bleeding disorders
  • Low white blood cell count below 2 x 10^9/L or low platelet count below 100 x 10^9/L
  • Scheduled surgical intervention before first study treatment dose
  • Pre-stroke modified Rankin Scale score greater than 2
  • Other severe diseases with expected life expectancy under 1 year
  • Psychiatric illness, cognitive impairment, or emotional disorders preventing study understanding or follow-up
  • Pregnant or breastfeeding women
  • Participation in another clinical trial within the past 3 months or currently enrolled in another trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

The First Affiliated Hospital of Wannan Medical University

Wuhu, Anhui, China

Not Yet Recruiting

2

Beijing Fengtai You'anmen Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

3

Beijing Tiantan Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

R

Ruijun Ji

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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