AI-Guided Hematoma Aspiration vs. Conservative Treatment for Spontaneous ICH
ConditionIntracerebral Hemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXiaolei Chen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed supratentorial hypertensive intracerebral hemorrhage on brain CT scan
Hematoma volume 20-50mL
Patients with with GCS score ≥8
Admitted within 24h of ictus
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
AI-Assisted Navigated Hematoma Aspiration
Procedure/SurgeryBy 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.
Conservative Treatment
Procedure/SurgeryCompared 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.
Treatment groups
680 Participants
are divided into 2 treatment groupsGroup A: AI-Assisted Navigated Hematoma AspirationExperimental treatment 1 intervention
Group B: Conservative TreatmentActive comparator 1 intervention
Trial outcomes
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.
Time frame
6 monthsSecondary outcomes
1
Postoperative Glasgow Coma Scale
A neurological scale to record the conscious state of patients at 1 week after surgery.
Time frame
7 days2
Days of ICU Stay
The time an ICH patient has to stay in intensive care unit after surgery.
Time frame
14 days3
Mortality
The percentage of patients that die within a month after the onset of hypertensive intracerebral hemorrhage.
Time frame
30 days4
WHO Quality of Life
The WHO Quality of Life-BREF comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. It is an international cross-culturally comparable quality of life assessment instrument.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiaolei Chen
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
Jingzhou Central Hospital
Collaborator
Wuhan No.1 Hospital
Collaborator
People's Hospital of Guangxi Zhuang Autonomous Region
Collaborator
Siping Central People's Hospital
Collaborator
Yichang Central People's Hospital
Collaborator
Peking University First Hospital
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Source ClinicalTrials.gov