Comparing neuroendoscopic surgery to craniotomy for large brain hemorrhages

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Rong Hu, MD
• Email: huchrong@aliyun.com
• Phone: 8615123917123

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.