AI-Guided Hematoma Aspiration vs. Conservative Treatment for Spontaneous ICH
Comparison of AI-assisted Navigated Hematoma Aspiration With Conservative Treatment for Spontaneous Intracerebral Hemorrhage: A Multicenter Randomized Controlled Trial
1 other identifier
interventional
680
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2020
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedFirst Posted
Study publicly available on registry
July 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2031
April 27, 2026
April 1, 2026
5.5 years
March 18, 2020
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
modified Rankin Scale
The degree of disability or dependence in the daily activities. The scale runs from 0-6, running from perfect health without symptoms to death.
6 months
Secondary Outcomes (5)
Postoperative Glasgow Coma Scale
7 days
Days of ICU Stay
14 days
Mortality
30 days
WHO Quality of Life
6 months
Medical expenses and health economic burden
up to 6 months
Study Arms (2)
AI-Assisted Navigated Hematoma Aspiration
EXPERIMENTALThis technique integrates AI-driven imaging analysis with navigation systems to enable accurate targeting and aspiration of intracerebral hematomas through a burr-hole approach, reducing surgical trauma and improving functional outcomes.
Conservative Treatment
ACTIVE COMPARATORConservative treatment for intracerebral hemorrhage involves medical management without surgical intervention, focusing on stabilizing the patient, controlling blood pressure, managing intracranial pressure, and preventing secondary complications.
Interventions
By leveraging AI algorithms for real-time hematoma segmentation, volume calculation, and trajectory optimization, this approach enhances the accuracy of minimally invasive catheter placement and facilitates efficient clot removal under image-guided navigation.
Compared to surgical hematoma aspiration, conservative treatment relies on medical stabilization and the body's natural clearance mechanisms, and remains the standard of care in many cases of moderate or deep-seated ICH without signs of clinical deterioration.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiaolei Chenlead
- Jingzhou Central Hospitalcollaborator
- Wuhan No.1 Hospitalcollaborator
- People's Hospital of Guangxi Zhuang Autonomous Regioncollaborator
- Siping Central People's Hospitalcollaborator
- Yichang Central People's Hospitalcollaborator
- Peking University First Hospitalcollaborator
- First Affiliated Hospital of Xinjiang Medical Universitycollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Related Publications (1)
Xu X, Zhang J, Yuan Q, Lang S, Gan Z, Jin H, Chen X. AI-driven navigated hematoma aspiration vs. conservative treatment for spontaneous intracerebral hemorrhage: study protocol for a randomized controlled trial. Trials. 2026 Apr 23. doi: 10.1186/s13063-026-09738-9. Online ahead of print.
PMID: 42021277DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaolei Chen, MD
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Patients' personal data are made anonymous and numbered by the system. A list of patient names and study numbers is kept in a separate file to ensure that patients' confidentiality is maintained.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 18, 2020
First Posted
July 22, 2025
Study Start
July 1, 2025
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
June 30, 2031
Last Updated
April 27, 2026
Record last verified: 2026-04