Status:
RECRUITING
Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage
Lead Sponsor:
Southwest Hospital, China
Conditions:
Intracerebral Haemorrhage
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a multicenter, randomized, controlled clinical trial comparing neuroendoscopic hematoma removal to craniotomy in the treatment of large intracerebral hemorrhage.
Detailed Description
Previous retrospective studies have demonstrated that neuroendoscopic surgery, compared to conventional craniotomy, significantly reduces operative duration and intraoperative blood loss, enhances hem...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT06894433
Start Date
June 1 2025
End Date
December 31 2028
Last Update
May 18 2025
Active Locations (2)
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1
Southwest Hospital
Chongqing, Chongqing Municipality, China, 400038
2
Dazhu County People's Hospital
Dazhou, Sichuan, China, 635100