RecruitingNot ApplicableNCT06894433

Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage

Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage: a Multicenter, Randomized, Controlled Clinical Trial

Sponsor

Southwest Hospital, China

Enrollment

280 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Intracerebral haemorrhage

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

Age 18-80 years old, male or female;
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);
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);
Before randomization, GCS score was 5-14, NIHSS score was ≥6;
mRS Before onset: 0-1 score;
Randomization within 24 hours after the first diagnostic CT;
The patient or family members are informed and voluntarily sign the informed consent;

Exclusion Criteria10

The clinical diagnosis is caused by cerebral aneurysm, cerebrovascular malformation, moyamoya disease, brain trauma, brain tumor, massive cerebral infarction hemorrhage transformation, coagulation dysfunction, etc.;
Thalamic hemorrhage, primary ventricular hemorrhage;
Platelet count <100×109/L, INR > 1.4;
Patients with advanced cerebral hernia (such as dilated bifidus and no light reflex) or unstable vital signs cannot tolerate surgery;
Irreversible brain stem impairment (eye fixation, bilateral pupil dilation), GCS≤4 points;
Any history of parenchyma or other intracranial subarachnoid, subdural or epidural blood and surgical history in the past 30 days;
Patients with severe advanced cognitive impairment (such as AD) or who are not expected to complete the follow-up plan as required;
Complicated with other serious diseases: including respiratory, circulation, digestion, urinary, endocrine, immune and blood systems;
Pregnant or breastfeeding women, or those who expect to become pregnant within one year;
are participating in other clinical trials (excluding: observational studies that do not involve intervention, natural history and/or epidemiological studies).