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.
aged 40 years or older;
the duration from onset to the baseline computed tomography angiography (CTA) scan was between 6 to 24 hours;
patients with a spontaneous ICH in the deep brain parenchyma (≥1 cm from the cortical surface); with hematoma volume more than 25 ml (measured with the ABC/2 method); without hydrocephalus caused by intraventricular hemorrhage; without cerebral herniation and the benefit of surgical treatment was unknown;
The Glasgow Coma Scale (GCS) ranged from 9 to 15;
ICH was caused by aneurysms, arteriovenous malformations, tumors, or trauma;
patients had a history of intracerebral hemorrhage or ischemic cerebral infarction;
patients had severe coagulation disorders with INR ≥ 1.5;
patients had severe underlying diseases, which may affect the outcomes;
First Affiliated Hospital of Fujian Medical University
Lead sponsor
Department of Science and Technology of Fujian province
Collaborator
Longyan City First Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Shanxi Provincial People's Hospital
Collaborator
Tangshan Gongren Hospital
Collaborator
Lanzhou University Second Hospital
Collaborator
Qilu Hospital of Shandong University (Qingdao)
Collaborator
The Second Hospital of Shandong University
Collaborator
Shishi General Hospital
Collaborator
Wuping County Hospital
Collaborator
Fuqing Municipal Hospital
Collaborator
Qingyuan People's Hospital
Collaborator
Jinjiang Municipal Hospital
Collaborator
Anxi County Hospital
Collaborator
Nanan Hospital
Collaborator
MinDong Hospital of Ningde City
Collaborator
Affiliated Hospital of Putian University
Collaborator
Lianjiang County Hospital
Collaborator
Shunchang County Hospital
Collaborator
Yulin No.2 Hospital
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
Second Affiliated Hospital of Xiamen Medical College
Collaborator
Zhangzhou Municipal Hospital of Fujian Province
Collaborator
Longyan People's Hospital of Fujian Province
Collaborator