Clinical trial NCT06894433: Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage
Official title: Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage: a Multicenter, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracerebral Haemorrhage
Keywords: intracerebral hemorrhage
neuroendoscopic
craniotomy
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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).

Primary outcomes:
measure: The proportion of patients with Modified Rankin Scale (mRS) score 0-3
timeFrame: 180 days
Secondary outcomes:
measure: Modified Rankin Scale (mRS) Score
timeFrame: 180 days
measure: mortality
timeFrame: 30 days, 90 days and 180 days
measure: Glasgow Outcome Scale Extended (GOS-E)
timeFrame: 180 days
measure: Assessment of cognitive function with Mini-Mental State Examination (MMSE)
timeFrame: 90 days and 180 days
measure: Quality of life measured with the 5-level EQ-5D (EQ-5D-5L)
timeFrame: 30 days and 180 days
measure: The proportion of patients with Modified Rankin Scale (mRS) score 0-2
timeFrame: 180 days
measure: Length of ICU
timeFrame: Number of days from admission, up to 180 days
measure: Length of hospitalization
timeFrame: Number of days from admission to discharge, up to 180 days
measure: The proportion of patients with Modified Rankin Scale (mRS) score 0-3
timeFrame: 30 days and 90 days
measure: Operation duration
timeFrame: From the beginning to the end of the surgery
measure: Peroperative bleeding
timeFrame: During surgery
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
city: Dazhou
country: China
facility: Dazhu County People's Hospital
state: Sichuan
Study officials:
affiliation: PLA Army Medical University
name: Rong Hu, MD
role: STUDY_CHAIR
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