Actively Recruiting
Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2025-02-12
400
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Fujian Medical University
Lead Sponsor
D
Department of Science and Technology of Fujian province
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a nationwide, multicenter, open-label, randomized controlled trial of early minimally invasive treatment for deep-seated spontaneous cerebral hemorrhage (dICH). The study consists of 2 steps: the first step is to conduct a dose climbing test to determine the safety and optimal dose of urokinase intra-hematoma irrigation after stereotactic aspiration; the second step is to validate whether stereotactic aspiration plus urokinase irrigation (the optimal dose determined in step one) is superior to conservative treatment in improving long-term outcomes (1 year) in early (within 24h) dICH patients.
CONDITIONS
Official Title
Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- Time from onset to baseline CTA scan between 6 to 24 hours
- Spontaneous intracerebral hemorrhage in deep brain parenchyma at least 1 cm from cortical surface
- Hematoma volume greater than 25 ml measured by ABC/2 method
- No hydrocephalus caused by intraventricular hemorrhage
- No cerebral herniation and unclear benefit from surgical treatment
- Glasgow Coma Scale score between 9 and 15
- Presence of motor deficits
- Modified Rankin Score between 0 and 1 before onset
You will not qualify if you...
- Intracerebral hemorrhage caused by aneurysms, arteriovenous malformations, tumors, or trauma
- History of intracerebral hemorrhage or ischemic cerebral infarction
- Severe coagulation disorders with INR 1.5 or higher
- Severe underlying diseases that may affect outcomes
- Pregnant or lactating patients
- Refusal to sign informed consent or receive follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
Research Team
L
Lin Fuxin, PHD,MD
CONTACT
K
Kang Dezhi, 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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