Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- Good functional outcome, measured by the modified Rankin Scale (mRS)
研究概览
简要总结
This is an open-labelled, single centre randomised controlled trial evaluating the efficacy of early minimally invasive image-guided hematoma evacuation in combination with the current best medical treatment compared to best medical treatment alone in improving functional outcome rates at 6 months after initial treatment in patients with spontaneous supratentorial intracerebral haemorrhage.
详细描述
Spontaneous supratentorial intracerebral haemorrhage (SSICH) is the second most common form of stroke and accounts for approximately 2500 cases in Switzerland annually. The prognosis is very poor with nearly half of the patients dying within one year after haemorrhage. Treatment options for SSICH consist of either the current gold standard, best medical treatment (BMT), or surgical hematoma evacuation. Neither the best medical treatment nor the established surgical mainstay (conventional craniotomy) have shown relevant improvement of survival or functional outcome rates. A minimal invasive approach with early image-guided endoscopic surgery conducted within 24 hours after bleeding onset is therefore proposed. Endoscopic surgery was shown to be safe and effective, however large trials analyzing the benefits of endoscopic surgery are lacking. An earlier, more complete and more rapid hematoma evacuation could improve the functional outcome and mortality rates in affected patients. The primary objective of this two-armed, open-labelled, single centre randomised controlled trial is to show superiority of early minimally invasive image-guided hematoma evacuation additionally to BMT compared to BMT alone in improving functional outcome rates at 6 months in patients with SSICH. The study procedures include 6 visits in total, 4 of them during hospital stay, 2 of them as follow-up visits within the clinical routine. Each visit consists of assessing Glasgow Coma Scale (GCS), modified Rankin Scale (mRS) and National Institute of Health Stroke Scale (NIHSS), three visits include CT scans (before intervention, directly postoperative and during follow up) and blood sampling (before intervention, postoperative and during follow up). Three visits include assessing patient satisfaction and cognition, and two visits include patient quality of life assessments. This study was designed in collaboration with Patient and Public representatives.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spontaneous supratentorial intracerebral hemorrhage (SSICH), defined as the sudden occurrence of bleeding into the lobar parenchyma and/or into the basal ganglia and/or thalamus that may extend into the ventricles confirmed by imaging
- •SSICH volume ≥20 mL <100 mL
- •A focal neurological deficit consisting of either
- •clinically relevant hemiparesis (≥4 motor points on the NIHSS for facial palsy, motoric upper and lower extremities combined)
- •clinically relevant motor or sensory aphasia (≥2 points on the NIHSS)
- •clinically relevant hemi-inattention (formerly neglect, 2 points on the NIHSS)
- •decreased level of consciousness (Glasgow Coma Scale (GCS)≤13)
- •Presenting GCS 5 - 15 (in intubated patients GCS assessment will be performed after Rutledge et al. or if impossible, the last pre-intubation GCS will be used)
- •Endoscopic hematoma evacuation can be initiated within 24 hours after the patient was last seen well/symptom onset
- •Informed consent of patient or appropriate surrogate (for patients without competence)
排除标准
- •SSICH due to known or suspected structural abnormality in the brain (e.g. vascular malformation, aneurysm, arteriovenous malformation (AVM), brain tumor) and/or brain trauma and/or hemorrhagic conversion of an ischemic infarction
- •Multiple simultaneous intracranial hemorrhages (ICH) (e.g. multifocal ICH, chronic subdural hematoma (cSDH), acute subdural hematoma (aSDH), SAH)
- •Infratentorial hemorrhage or midbrain extension/involvement of the hemorrhage
- •Coagulation disorder (including anticoagulation) with an international normalized ratio (INR) of >1.5 which cannot be pharmacologically reverted until the planned time of evacuation
- •Pregnancy
- •Relevant disability prior to SSICH (mRS >2)
- •Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 180 days (e.g. bilateral fixed dilated pupils)
结局指标
主要结局
Good functional outcome, measured by the modified Rankin Scale (mRS)
时间窗: At 6 months after treatment
Good functional outcome is defined as a mRS of ≤3 points and will be assessed as binary outcome (yes/no, final value). In this context, a mRS score of 3 points reflects the ability to walk unassisted and care for one's own bodily needs despite being moderately dependent on assistance, while a mRS score of 4 points describes a patient who is not able to walk anymore and needs assistance with all daily activities and thus marks a severe loss of patient autonomy.
次要结局
- Mortality rate(At 6 and 12 months after intervention)
- Change of focal neurological deficit measured by the National Institute of Health Stroke Scale (NIHSS)(From baseline to 6 months after intervention)
- Time to intervention(At baseline)
- Total time spent in intubation measured in minutes(At 7 days/discharge after intervention)
- Proportion of hematoma volume reduction rate (in the intervention group only)(Directly after intervention)
- Change in Patient cognitive outcome as assessed by the Montreal-Cognitive-Assessment-Test (MOCA® )(At 3 and 6 months after intervention)
- Change in Quality of Life, assessed by Patient-Reported Outcomes Measurement Information System (PROMIS®) questionnaire(At 3 and 6 months after intervention)
- Morbidity rate(At 6 and 12 months after intervention)
- Change in Patient Satisfaction Questionnaire(At 3 and 6 months after intervention)
- Total time spent on the intensive care unit (ICU)/stroke unit(At 7 days/discharge after intervention)