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Safety and efficacy of neuroendoscopic surgery versus craniotomy for large supratentorial intracerebral hemorrhage: a multicenter, randomized, controlled clinical trial (NESICH 2).

Safety and efficacy of neuroendoscopic surgery versus craniotomy for large supratentorial intracerebral hemorrhage: a multicenter, randomized, controlled clinical trial (NESICH 2).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104840
Enrollment
Unknown
Registered
2025-06-24
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supratentorial intracerebral hemorrhage

Interventions

Treatment group:Neuroendoscopic surgery

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion 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

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 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.Participating in other clinical trials (excluding: observational studies that do not involve intervention, natural history and/or epidemiological studies).

Design outcomes

Primary

MeasureTime frame
The proportion of patients with mRS Scores of 0-3 in the two groups at 180 days of the onset;

Secondary

MeasureTime frame
Complication rate;Incidence of adverse and serious adverse events;Ratio of mRS Rating 0-3;Quality of Life Assessment (EQ-5D-5L);Neurological function improvement (mRS) of the two groups at 180 days after onset;MMSE;Average intraoperative blood loss and blood transfusion;mRS 0-2 points ratio;After 180 days of treatment, mRS Scores were performed on the patients, and the proportion of mRS 0-2 scores in the two groups was calculated;Incidence of rebleeding and infection;GOSE;Patient mortality;Average operation time;

Countries

China

Contacts

Public ContactRong Hu

The First Affiliated Hospital of Army Medical University

huchrong@tmmu.edu.cn+86 151 2391 7123

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026