RecruitingNot Applicable

Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage

China280 participantsStarted 2025-06-01

Plain-language summary

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

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

The proportion of patients with Modified Rankin Scale (mRS) score 0-3

Timeframe: 180 days

Trial details

NCT IDNCT06894433

SponsorSouthwest Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-30

Contact for this trial

Rong Hu, MD

8615123917123 huchrong@aliyun.com

View on ClinicalTrials.gov More Intracerebral Haemorrhage trials