Intracerebral Haemorrhage
Conditions
Keywords
intracerebral hemorrhage, neuroendoscopic, craniotomy
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.
Interventions
PROCEDUREneuroendoscopic surgery
Subjects will receive Neuroendoscopic Surgery followed by standard medical management
PROCEDUREcraniotomy
Subjects will receive Craniotomy followed by standard medical management
Sponsors
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with Modified Rankin Scale (mRS) score 0-3 | 180 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality | 30 days, 90 days and 180 days | All cause mortality from onset to 180 days |
| Glasgow Outcome Scale Extended (GOS-E) | 180 days | 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. |
| Assessment of cognitive function with Mini-Mental State Examination (MMSE) | 90 days and 180 days | The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. |
| Quality of life measured with the 5-level EQ-5D (EQ-5D-5L) | 30 days and 180 days | The EQ-5D-5L is a standard measure of health-related quality of life.EQ-5D-5L consists of two components: a health state profile and a visual analog scale (VAS). EQ-5D health state profile comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where a higher score indicates a better health state. The VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating the worst health you can imagine and 100 indicating the best health you can imagine. Higher scores of EQ VAS indicate better health. |
| The proportion of patients with Modified Rankin Scale (mRS) score 0-2 | 180 days | 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. |
| Modified Rankin Scale (mRS) Score | 180 days | 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. |
| Length of hospitalization | Number of days from admission to discharge, up to 180 days | Duration of stay in the hospital |
| The proportion of patients with Modified Rankin Scale (mRS) score 0-3 | 30 days and 90 days | 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. |
| Operation duration | From the beginning to the end of the surgery | The length of the operation |
| Peroperative bleeding | During surgery | The amount of blood lost during surgery |
| Length of ICU | Number of days from admission, up to 180 days | Duration of stay in the ICU |
Countries
China
Contacts
Primary ContactRong Hu, MD
Backup ContactHua Feng, MD
Outcome results
None listed