Spontaneous cerebral hemorrhage is one of the main causes of death and disability all over the world, accounting for 20%-30% of all cerebrovascular diseases. Minimally invasive surgery of cerebral hemorrhage, especially puncture aspiration, can improve early and long-term neurological recovery in patients with cerebral hemorrhage. Until now, no standardized practice for minimally invasive surgery of spontaneous cerebral hemorrhage has been established. Hematoma puncture and drainage based on CT scans without precise localization and personalized approach design, which may lead to poor efficacy and high risk of complications. Our hospital has much experience in treating cerebral hemorrhage with stereotactic puncture and aspiration. So we conduct a prospective multicenter randomized controlled clinical trial to determine the therapeutic effects of puncture aspiration plus thrombolysis treatment for the perioperative and long-term recovery of patients with small to moderate hematoma in deep basal ganglia via computerized precision coordinates and personalized approach design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
380
stereotactic puncture and aspiration to evacuate basal ganglion hematoma with or without thrombolytic agent
Guideline-based standard medical management
the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Favorable Functional Outcome as Defined by the modified Rankin Scale (mRS) Score
Functional independence is defined as achieving a score of 0, 1, or 2 on the mRS. The mRS is a 7-point scale that measures the degree of disability or dependence in the daily activities of patients who have had a stroke. The scale ranges from 0 (no symptoms) to 6 (dead).
Time frame: 180 days
All-Cause Mortality
Time frame: 180 days
Barthel Index (BI)
Functional status in activities of daily living (ADL) will be assessed using the Barthel Index (BI). The BI score ranges from 0 (completely dependent) to 100 (fully independent).
Time frame: 180 days
Glasgow Outcome Scale-Extended (GOS-E) score
The GOS-E is an 8-point scale that categorizes global outcomes from Dead (1) to Upper Good Recovery (8).
Time frame: 180 days
Residual Hematoma Volume
Absolute volume (in mL) of the hematoma remaining at 24 hours (± 6 hours) and at 1 month (± 7 days) post-randomization
Time frame: 24 hours and one month
Length of Initial Hospital Stay
Total duration (in days) of the index hospitalization from admission to discharge (excluding transfers to other acute care facilities)
Time frame: one month
Total direct medical costs during the index hospitalization
Total direct healthcare costs related to the index ICH event incurred during the index hospitalization, assessed from a healthcare system perspective
Time frame: one month
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