Actively Recruiting
Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage
Led by Southwest Hospital, China · Updated on 2024-05-10
560
Participants Needed
4
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To compare the efficacy and safety of neuroendoscopic hematoma removal and standard conservative treatment for patients with spontaneous supratentorial deep intracerebral hemorrhage.
CONDITIONS
Official Title
Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, any gender
- Time from symptom onset to first diagnostic CT scan within 24 hours
- Deep supratentorial cerebral hemorrhage in specified brain areas with hematoma volume of 25 ml or more
- Hematoma stability confirmed by two CT scans after onset, with additional scans if needed
- Pre-randomization Glasgow Coma Scale (GCS) score between 5 and 14 and/or NIH Stroke Scale (NIHSS) score of 6 or higher
- Modified Rankin Scale (mRS) score of 0 or 1 before onset
- Blood pressure consistently controlled at 180 mmHg or below for 6 hours before randomization
- Randomization completed within 24 hours after first CT, with surgery performed within 6 hours after randomization (no later than 54 hours after onset)
- Informed consent signed by patient or family
You will not qualify if you...
- Hemorrhage caused by cerebral aneurysm, cerebrovascular malformation, moyamoya disease, traumatic brain injury, brain tumor, hemorrhagic transformation of large cerebral infarct, or coagulation dysfunction
- Lobar, thalamic, primary ventricular, cerebellar, or brain stem hemorrhages
- Hematoma involving midbrain with dilated or unresponsive pupils
- Life-threatening hematoma effects such as midline brain shift over 1 cm or loss of cisterna ambiens, or patients too unstable for enrollment
- Platelet count below 100×10^9/L or INR above 1.4
- Hematoma extending into ventricles and completely blocking third or fourth ventricle
- History of cerebral hemorrhage within the past year
- Severe liver impairment (ALT or AST 3 times above normal) or severe kidney failure (glomerular filtration rate below 30 ml/min/1.73 m²)
- Blood pressure not controlled below 180 mmHg despite aggressive treatment before randomization
- Severe cognitive impairment or psychiatric disorders preventing follow-up
- Other serious diseases affecting respiratory, circulatory, digestive, urinary, endocrine, immune, or blood systems
- Pregnant or breastfeeding women or those planning pregnancy within one year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
chongqing Emergency Medical Center
Chongqing, Chongqing Municipality, China, 400014
Actively Recruiting
2
Xiang Yang NO.1 Peoples Hospital
Hubei, Hubei, China, 441000
Actively Recruiting
3
Dazhu County People's Hospital
Sichuan, Sichuan, China, 635100
Actively Recruiting
4
Ganzhou city people's Hospita
Ganzhou, China
Actively Recruiting
Research Team
R
Rong Hu, MD
CONTACT
H
Hua Feng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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