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Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation
Sponsor: First Affiliated Hospital of Fujian Medical University
Summary
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.
Official title: Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation: a Multicentral Randomized, Controlled, Open-label, Trial
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2021-01-31
Completion Date
2025-09-30
Last Updated
2025-02-12
Healthy Volunteers
No
Interventions
STAPLE
Stereotactic aspiration plus urokinase clot irrigation
Locations (1)
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China