Comparing neuroendoscopic surgery to craniotomy for large brain hemorrhages

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

This study is testing if a newer type of brain surgery called neuroendoscopic surgery is safer and more effective than traditional surgery for treating large brain bleeds in adults aged 18 to 80.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Southwest Hospital, China (Academic / other)
• Locations: 2 sites (Chongqing, Chongqing Municipality and 1 other locations)
• Trial ID: NCT06894433 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, controlled clinical trial aims to evaluate the efficacy and safety of neuroendoscopic surgery compared to traditional craniotomy in treating large intracerebral hemorrhages. Previous studies suggest that neuroendoscopic techniques may lead to shorter surgery times, less blood loss, and better recovery outcomes. The trial will involve patients aged 18-80 with significant intracerebral hemorrhages, and will assess various postoperative outcomes to provide evidence-based guidance for surgical decisions. The study seeks to fill a gap in the current literature regarding the best surgical approach for this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with significant supratentorial intracerebral hemorrhages requiring emergency surgery.

Not a fit: Patients with hemorrhages caused by cerebral aneurysms or vascular malformations will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients suffering from large intracerebral hemorrhages.

How similar studies have performed: While previous studies have shown promising results for neuroendoscopic surgery, this trial is among the first prospective randomized controlled evaluations of this approach.

Eligibility criteria

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).

Where this trial is running

Chongqing, Chongqing Municipality and 1 other locations

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

Study contacts

• Study coordinator: Rong Hu, MD

Conditions Intracerebral Haemorrhage; intracerebral hemorrhage; neuroendoscopic; craniotomy