Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage: a Randomised, Controlled, Open-label, Blinded Endpoint Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 560
- 试验地点
- 4
- 主要终点
- Safety outcome
研究概览
简要总结
To compare the efficacy and safety of neuroendoscopic hematoma removal and standard conservative treatment for patients with spontaneous supratentorial deep intracerebral hemorrhage.
详细描述
Neuroendoscopic treatment of spontaneous intracerebral hemorrhage (ICH) is more and more widely used, but multi-center clinical study on the efficacy and safety of neuroendoscopic treatment of ICH is relatively small. Based on the lack of sufficient clinical evidence, the investigators plan to conduct a prospective, multicenter, randomized controlled clinical trial to investigate the safety and efficacy of neuroendoscopy in the treatment of spontaneous cerebral parenchymal hemorrhage, so as to provide evidence-based medical evidence for endoscopic minimally invasive treatment of cerebral hemorrhage and its application.The aim of trial was to determine whether the endoscopic surgery could achieve the benefits of clot evacuation and improve functional outcome at 180 days after ICH without procedure-related safety events or additional brain injury beyond the risks associated with standard care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, either sex.
- •Time from onset to the first diagnostic CT within 24 hours (for those without bystanders and with unknown onset time, use the last known time the patient was in good condition)
- •Deep (external capsule, putamen, internal capsule, caudate nucleus) supratentorial cerebral hemorrhage with a hematoma volume ≥ 25 ml.
- •Stability of the hematoma determined by two CT scans at different times after onset. If the hematoma enlarges 5ml then the stability of the hematoma can be detected by CT again after 6 hours until the randomization time window is closed.
- •Pre-randomization GCS score of 5-14 and/or NIHSS score of ≥
- •Pre-onset Modified Rankin Scale (mRS) score 0 or
- •Blood pressure recorded 6 hours prior to randomization consistently controlled at 180 mmHg or less.
- •Randomization completed within 24 hours after the first diagnostic CT, and surgical intervention should be performed as soon as possible, no later than 6 hours after randomization, that is to say, surgery should be performed no later than 54 hours after onset.
- •Informed and voluntarily signed informed consent by the patient or family.
排除标准
- •Hemorrhage clinically diagnosed as a result of cerebral aneurysm, cerebrovascular malformation, moyamoya disease, traumatic brain injury, brain tumor, hemorrhagic transformation of a large cerebral infarct, coagulation dysfunction.
- •Lobar hemorrhages, thalamic hemorrhages, primary ventricular hemorrhages, cerebellum hemorrhages and brain stem hemorrhages.
- •Hematoma involving the midbrain, with dilated or unresponsive pupils.
- •Hematoma producing life-threatening occupying effects (e.g., CT showing midline deviation of more than 1 cm, loss of cisterna ambiens) or patients who are extremely unstable and unfit for enrollment.
- •Platelet count <100×10^9/L, international normalized ratio (INR) >1.
- •Hematoma extension to ventricle and completely blocked the third or fourth ventricle.
- •Recent history of cerebral hemorrhage (less than 1 year).
- •Severe hepatic impairment with ALT 3 times the upper limit of normal, or AST 3 times the upper limit of normal. Severe renal insufficiency with glomerular filtration rate less than 30 ml/min/1.73 m
- •Blood pressure not effectively controlled to less than 180 mmHg despite aggressive antihypertensive therapy prior to randomization.
- •Patients with severe advanced cognitive impairment (e.g. AD) or psychiatric disorders who are unable to complete the follow-up program as required.
- •Comorbid other serious diseases such as respiratory, circulatory, digestive, urological, endocrine, immune and hematologic disorders.
- •Pregnant or lactating women, or those who expect to become pregnant within one year.
结局指标
主要结局
Safety outcome
时间窗: 180 days
All cause mortality from onset to 180 days
The proportion of patients with Modified Rankin Scale (mRS) score 0-3
时间窗: 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.
次要结局
- Length of hospitalization(Number of days from admission to discharge, up to 180 days)
- Assessment of cognitive function with Mini-Mental State Examination (MMSE)(180 days.)
- Quality of life measured with the 5-level EQ-5D (EQ-5D-5L)(180 days.)
- Modified Rankin Scale (mRS) Score(90 days .)
- Survival rate(90 days.)
- Glasgow Outcome Scale Extended (GOS-E)(180 days.)
- Length of ICU(Number of days from admission, up to 180 days)
- In-hospital cost(Number of days from admission to discharge, up to 180 days)
研究者
Rong Hu, MD
Director of Department of Neurosurgery
Southwest Hospital, China