Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07077343

AI-Guided Hematoma Aspiration vs. Conservative Treatment for Spontaneous ICH

Led by Xiaolei Chen · Updated on 2026-04-27

680

Participants Needed

1

Research Sites

312 weeks

Total Duration

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Sponsors

X

Xiaolei Chen

Lead Sponsor

J

Jingzhou Central Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

The effectiveness of traditional craniotomy in the treatment of intracerebral hemorrhage remains controversial. Minimally invasive surgery, specially, image-guided hematoma aspiration, proves to be effective and may have some advantages compared with craniotomy. This multicenter randomized controlled trial aims to evaluate and compare the clinical efficacy of two minimally invasive treatment strategies for patients with spontaneous supratentorial intracerebral hemorrhage (ICH) with moderate hematoma volume (20-50 mL): (1) AI-assisted, navigation-guided hematoma aspiration, and (2) targeted pharmacological therapy. This study is designed to address the current lack of prospective comparative evidence between advanced image-guided surgical intervention and medical management in this specific patient population. By focusing on functional recovery, hematoma resolution, and safety outcomes, this trial seeks to provide high-quality evidence to guide treatment decision-making and optimize individualized care for patients with spontaneous ICH.

CONDITIONS

Official Title

AI-Guided Hematoma Aspiration vs. Conservative Treatment for Spontaneous ICH

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed supratentorial hypertensive intracerebral hemorrhage on brain CT scan
  • Hematoma volume 20-50mL
  • Patients with GCS score 658
  • Admitted within 24 hours of ictus
Not Eligible

You will not qualify if you...

  • Intracerebral hemorrhage caused by tumor, coagulopathy, aneurysm, or arteriovenous malformation
  • Concurrent head injury or history of head injury
  • Multiple intracerebral hemorrhage
  • Known advanced dementia or disability before
  • Severe concomitant diseases that affect life expectancy
  • Severe intraventricular hemorrhage
  • Pregnant women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chinese PLA General Hospital

Beijing, Beijing Municipality, China, 100853

Actively Recruiting

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Research Team

X

Xinghua Xu, MD

CONTACT

Q

Qun Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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