AI-Guided Hematoma Aspiration vs. Conservative Treatment for Spontaneous ICH
Recruiting now · Not applicable
Conditions studied: Intracerebral Hemorrhage
In brief
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.
Key facts
- Study ID
- NCT07077343
- Run by
- Xiaolei Chen
- People needed
- 680
- Starts
- 2025-07-01
- Expected to finish
- 2031-06-30
- Last updated by the study team
- 2026-04-27
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed supratentorial hypertensive intracerebral hemorrhage on brain CT scan
- Hematoma volume 20-50mL
- Patients with with GCS score ≥8
- Admitted within 24h of ictus
You may not qualify if…
- Intracerebral hemorrhage caused by tumor, coagulopathy, aneurysm, or arteriovenous malformation
- Concurrent head injury or history of head injury
- Multiple intracerebral hemorrhage
- Known advanced demential or disability before
- Severe concomitant diseases that affect life expectancy
- With severe intraventricular hemorrhage
- Pregnant women
Where it is running
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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