NCT07077343 AI-Guided Hematoma Aspiration vs. Conservative Treatment for Spontaneous ICH
| NCT ID | NCT07077343 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiaolei Chen |
| Condition | Intracerebral Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 680 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 680 participants in total. It began in 2025-07-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Confirmed supratentorial hypertensive intracerebral hemorrhage on brain CT scan * Hematoma volume 20-50mL * Patients with with GCS score ≥8 * Admitted within 24h of ictus Exclusion Criteria: * 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 & Investigator
Xiaolei Chen, MD
PRINCIPAL INVESTIGATOR
Chinese PLA General Hospital
Frequently Asked Questions
Who can join the NCT07077343 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Intracerebral Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07077343 currently recruiting?
Yes, NCT07077343 is actively recruiting participants. Contact the research team at dr_xxh@126.com for enrollment information.
Where is the NCT07077343 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07077343 clinical trial?
NCT07077343 is sponsored by Xiaolei Chen. The principal investigator is Xiaolei Chen, MD at Chinese PLA General Hospital. The trial plans to enroll 680 participants.