Safety and Efficacy of Stereotactic Aspiration Plus Urokinase in Deep Intracerebral Hemorrhage Evacuation

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.

NCT Number	NCT04686877
Lead Sponsor	First Affiliated Hospital of Fujian Medical University Collaborators: Department of Science and Technology of Fujian province, Longyan City First Hospital, The First Affiliated Hospital of Zhengzhou University, Shanxi Provincial People's Hospital, Tangshan Gongren Hospital, Lanzhou University Second Hospital, Qilu Hospital of Shandong University (Qingdao), The Second Hospital of Shandong University, Shishi General Hospital, Wuping County Hospital, Fuqing Municipal Hospital, Qingyuan People's Hospital, Jinjiang Municipal Hospital, Anxi County Hospital, Nanan Hospital, MinDong Hospital of Ningde City, Affiliated Hospital of Putian University, Lianjiang County Hospital, Shunchang County Hospital, Yulin No.2 Hospital, The First Affiliated Hospital of Xiamen University, Second Affiliated Hospital of Xiamen Medical College, Zhangzhou Municipal Hospital of Fujian Province, Longyan People's Hospital of Fujian Province
Conditions	Treatment of Spontaneous Intracerebral Hemorrhage
Enrollment	400 participants
Start Date	2021-01-31
Primary Completion	2025-08-31 (estimated)
Study Completion	2025-09-30 (estimated)
Updated on ClinicalTrials.gov	2025-02-12