Ireland
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Recruiting Not applicable

Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage

NCT06894433 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-06-01
Last updated
2025-05-18

Condition(s) studied

Intracerebral Haemorrhage

Investigational drug(s) / intervention(s)

neuroendoscopic surgerycraniotomy

neuroendoscopic surgery: Subjects will receive Neuroendoscopic Surgery followed by standard medical management

craniotomy: Subjects will receive Craniotomy followed by standard medical management

Study summary

This is a multicenter, randomized, controlled clinical trial comparing neuroendoscopic hematoma removal to craniotomy in the treatment of large intracerebral hemorrhage.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-80 years old, male or female; 2. The time between onset and admission to the first diagnostic CT is within 24 hours (for no bystanders and the time of onset is unknown, the time of the last known patient in good condition is used); 3. Patients with supratentorial intracerebral hemorrhage (supratentorial intracerebral hemorrhage (supratentorial intracerebral hemorrhage) whose hematoma volume is ≥50ml or whose hematoma produces obvious space occupying effect and requires emergency surgery (including patients with cerebral hernia signs such as retarding or dilatation of light reflex of one pupil); 4. Before randomization, GCS score was 5-14, NIHSS score was ≥6; 5. mRS Before onset: 0-1 score; 6. Randomization within 24 hours after the first diagnostic CT; 7. The patient or family members are informed and voluntarily sign the informed consent; Exclusion Criteria: 1. The clinical diagnosis is caused by cerebral aneurysm, cerebrovascular malformation, moyamoya disease, brain trauma, brain tumor, massive cerebral infarction hemorrhage transformation, coagulation dysfunction, etc.; 2. Thalamic hemorrhage, primary ventricular hemorrhage; 3. Platelet count \<100×109/L, INR \> 1.4; 4. Patients with advanced cerebral hernia (such as dilated bifidus and no light reflex) or unstable vital signs cannot tolerate surgery; 5. Irreversible brain stem impairment (eye fixation, bilateral pupil dilation), GCS≤4 points; 6. Any history of parenchyma or other intracranial subarachnoid, subdural or epidural blood and surgical history in the past 30 days; 7. Patients with severe advanced cognitive impairment (such as AD) or who are not expected to complete the follow-up plan as required; 8. Complicated with other serious diseases: including respiratory, circulation, digestion, urinary, endocrine, immune and blood systems; 9. Pregnant or breastfeeding women, or those who expect to become pregnant within one year; 10. are participating in other clinical trials (excluding: observational studies that do not involve intervention, natural history and/or epidemiological studies).

Primary outcome measure(s)

  • The proportion of patients with Modified Rankin Scale (mRS) score 0-3 — 180 days
    Functional outcome (comparing the intervention group to the control), assessed with the modified Rankin Scale (mRS) at 6 months.The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death.

Trial sites (2)

FacilityCityRegionStatus
Southwest Hospital Chongqing Chongqing Municipality Recruiting
Dazhu County People's Hospital Dazhou Sichuan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06894433 on ClinicalTrials.gov ↗ ← All trials in China