Skip to content

Clinical application and efficacy of new laser positioning combined with soft-channel minimally invasive surgery in the treatment of spontaneous cerebral haemorrhage

Clinical application and efficacy of new laser positioning combined with soft-channel minimally invasive surgery in the treatment of spontaneous cerebral haemorrhage

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094351
Enrollment
Unknown
Registered
2024-12-20
Start date
2023-01-15
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous intracerebral hemorrhage

Interventions

Intervention group:Laser stereotactic intracerebral hematoma soft channel puncture aspiration and drainage
Control group:hard channel hematoma puncture and drainage

Sponsors

Nanchuan District People's Hospital of Chongqing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) aged 18-85 years old 2) Spontaneous cerebral hemorrhage diagnosed by head CT examination (hemorrhage sites mainly from basal ganglia, thalamus, brain stem and cerebellum) 3) The volume of hematoma was 20-40ml in the basal ganglia, >10ml in the thalamus, >5ml in the brain stem, >10ml in the cerebellum, and the midline structure was shifted less than 3mm at the level of the pineal gland. The hematoma volume was calculated by the formula V (cm3) =A×B×C×1/2. A is the longest diameter (cm) of the largest slice of the hematoma in the horizontal plane of plain CT scan, B is the widest diameter (cm) of the hematoma perpendicular to A on the plane, and C is the thickness of the hematoma in the CT image (cm). 4), GCS score 4-14 5), and NIHSS score >=6 6), unilateral muscle strength of the symptomatic side 0-4 grade 7), mRS Score >=0-1 before onset 8), patients and their legal representatives agreed to participate in the study and signed written informed consent

Exclusion criteria

Exclusion criteria: 1) Unstable vital signs (weak spontaneous breathing or no spontaneous breathing requiring mechanical assisted ventilation, hypotension, severe arrhythmia), large amount of bleeding combined with cerebral herniation, requiring immediate craniotomy to remove hematoma and decompressive craniectomy to relieve intracranial pressure and cerebral herniation; 2) hemorrhage caused by other causes (such as aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhagic transformation of massive cerebral infarction, hemorrhage caused by ß-amyloid disease, hemorrhage caused by coagulopathy) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, massive cerebral infarction, ß-amyloid disease, severe coagulopathy; 3) recent history of cerebral hemorrhage ( 1.4; 11) anticipated need for long-term anticoagulation and antiplatelet therapy; 12) previous history of internal bleeding, such as gastrointestinal bleeding, urogenital system bleeding, respiratory tract bleeding is not completely controlled; 13) myocardial infarction within the past 30 days; 14) known to be at high embolic risk, including patients with intracorporeal mechanical heart valves, a history of thrombosis on the left side of the heart, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral-valve stenosis is appropriate; 15) severe liver damage, ALT > 3 times upper limit of normal, or AST > 3 times upper limit of normal. Severe renal insufficiency, glomerular filtration rate 180mmHg) before randomization; 17) patients with Alzheimer's disease or mental illness who are unable to complete the follow-up plan as required; 18) combined with any serious diseases that may interfere with the test results: including diseases of the respiratory system, circulatory system, digestive system, urogenital system, endocrine system, immune system and blood system; 19) current drug or alcohol abuse or dependence, poor compliance is expected to be difficult to complete the follow-up; 20) allergy to urokinase or surgery-related drugs or instruments; 21) pregnant or breastfeeding women, or those planning to become pregnant within 1 year; 22) life expectancy less than 12 months due to advanced stage of any disease; 23) patients or their legal guardians were unwilling to provide written informed consent

Design outcomes

Primary

MeasureTime frame
Patient's neurological function score after six months of treatment (mRS rating);

Secondary

MeasureTime frame
Effective hematoma clearance rate;mortality rate;Incidence of complications;

Countries

China

Contacts

Public ContactAi Chen

Nanchuan District People's Hospital of Chongqing

chazhuyy@126.com+86 136 5828 9527

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026