Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage

Recruiting now · Not applicable

Conditions studied: Intracerebral Haemorrhage

In brief

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

Key facts

Study ID

NCT06894433

Run by

Southwest Hospital, China

People needed

280

Starts

2025-06-01

Expected to finish

2028-12-31

Last updated by the study team

2025-05-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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).

Where it is running

• Southwest Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• Dazhu County People's Hospital — Dazhou, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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