Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage

Southwest Hospital, China280 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

280

Conditions

Intracerebral Haemorrhage

Interventions

neuroendoscopic surgeryPROCEDURE

Subjects will receive Neuroendoscopic Surgery followed by standard medical management

craniotomyPROCEDURE

Subjects will receive Craniotomy followed by standard medical management

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Locations (2)

Southwest Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Dazhu County People's Hospital

Dazhou, Sichuan, China

RECRUITING

Outcomes

Primary Outcomes

The proportion of patients with Modified Rankin Scale (mRS) score 0-3

Functional outcome (comparing the intervention group to the control), assessed with the modified Rankin Scale (mRS) at 6 months.The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death.

Time frame: 180 days

Secondary Outcomes

Modified Rankin Scale (mRS) Score

The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death.

Time frame: 180 days

mortality

All cause mortality from onset to 180 days

Time frame: 30 days, 90 days and 180 days

Glasgow Outcome Scale Extended (GOS-E)

GOS-E subdivides the categories of severe and moderate disability and good recovery using a scale of 1 to 8 where 1 = death, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery. Structured telephone interviews have been developed and validated for the GOS-E and these questions were incorporated into the follow-up survey. GOS-E was dichotomized into unfavorable (1 to 4) and favorable (5 to 8) outcomes.

Time frame: 180 days

Assessment of cognitive function with Mini-Mental State Examination (MMSE)

Central Contacts

Rong Hu, MD

CONTACT

8615123917123 huchrong@aliyun.com

Hua Feng, MD

CONTACT

8613708321681 fenghua201818@aliyun.com

Data from ClinicalTrials.gov

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