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;
Parallel
STAPLE
Procedure/SurgeryStereotactic aspiration plus urokinase clot irrigation
Good functional outcome, measured by the modified Rankin Scale (mRS)
Good functional outcome is defined as a mRS of ≤3 points and will be assessed as binary outcome (yes/no, final value). In this context, a mRS score of 3 points reflects the ability to walk unassisted and care for one's own bodily needs despite being moderately dependent on assistance, while a mRS score of 4 points describes a patient who is not able to walk anymore and needs assistance with all daily activities and thus marks a severe loss of patient autonomy.
Proportion of hematoma evacuation by craniotomy or decompressive hemicraniectomy
Number of participants who were converted to hematoma evacuation by craniotomy or decompressive hemicraniectomy for reasons such as hematoma enlargement after conservative treatment or urokinase treatment.
Residual hematoma volume
Proportion of patients with hematoma volume reduced to less than 10mL \[binary outcome (yes/no)\]. The hematoma volume will be measured on cranial computer tomography (cCT) at day 7 after randomization in the Conservative Treatment group and 72 hours after the last urokinase infusion in the STAPLE group.
All-cause mortality
Mortality rate as measured by death of a participant \[binary outcome (yes/no)\]. Death induced by any cause.
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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
