Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage (NESICH 2)

Army Medical University

Status: Enrolling

Conditions: Intracerebral Haemorrhage

Treatments: Procedure: neuroendoscopic surgery; Procedure: craniotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06894433

Neurosurg 05

Details and patient eligibility

About

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

Full description

Previous retrospective studies have demonstrated that neuroendoscopic surgery, compared to conventional craniotomy, significantly reduces operative duration and intraoperative blood loss, enhances hematoma evacuation rates, and improves postoperative outcomes, including neurological recovery, activities of daily living, and quality of life in patients with large cerebral hemorrhage. However, there is a paucity of prospective randomized controlled trials evaluating the efficacy of different surgical techniques for intracerebral hemorrhage. To address this gap, the investigators propose a multicenter, randomized, controlled clinical trial to compare the safety and efficacy of neuroendoscopic surgery versus craniotomy, aiming to provide evidence-based guidance for surgical decision-making in cerebral hemorrhage management.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

Experimental Arm

Experimental group

Description:

Neuroendoscopic Surgery to remove intracranial hematoma

Treatment:

Procedure: neuroendoscopic surgery

Control Arm

Active Comparator group

Description:

Craniotomy to remove intracranial hematoma

Treatment:

Procedure: craniotomy