Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment (EVACUATE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 26
- 主要终点
- Dichotomized Modified Rankin Scale Score 0-3 vs. 4-6 at 6 months post-onset (Adjusted)
研究概览
简要总结
A randomized controlled trial of ultra-early, minimally invasive, hematoma evacuation versus standard care within 8 hours of intracerebral hemorrhage. Patients presenting to the emergency department with stroke due to supratentorial, spontaneous intracerebral hemorrhage >20mL volume will be assessed to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomized 50:50 using central computerized allocation to minimally invasive hematoma evacuation using the Aurora surgiscope and evacuator (Integra Lifesciences) versus standard medical therapy. The trial is prospective, randomized, open-label, blinded endpoint (PROBE) design with seamless phase 2b-3 transition if the intermediate endpoint (successful hematoma evacuation) is met in analysis of the first 52 patients. Adaptive sample size re-estimation (Mehta and Pocock) will be performed when 160 patients have completed 6 month follow-up (minimum sample size 240, maximum sample size 434).
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)
盲法说明
The primary outcome of Modified Rankin scale (mRS) and secondary outcomes including National Institutes of Health Stroke Scale (NIHSS) are assessed by a blinded clinician.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an acute supratentorial intracerebral hemorrhage (ICH) ≥20mL in volume
- •Age ≥18 years
- •Surgery can commence within 8 hours of symptom onset (the time the patient was last known to be well) or, in patients with wake-up onset, within 8 hours of the time the patient awoke with symptoms. Patients presenting with small ICH (volume <20mL) with clinical deterioration judged due to ICH hematoma expansion meeting volume criteria may be randomized if surgery can commence within 8 hours of clinical deterioration
- •Moderate neurological deficit (NIHSS≥6)
- •Pre-stroke mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).
- •CTA or MRA is performed and does not show an underlying vascular lesion
排除标准
- •Brainstem ICH
- •ICH secondary to trauma, where brain injury is judged more likely to be due to the broad effects of trauma rather than the focal ICH.
- •Hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency (in liver disease, INR>1.4).
- •Platelet count <75,000
- •Unreversible heparinization or anticoagulation. If reversing warfarin, INR should be ≤1.4 before procedure commences. Reversal of heparin by protamine, dabigatran by idarucizumab and rivaroxaban, apixaban and enoxaparin by andexanet (where available) is permitted. Unreversed anticoagulation with a last dose within 48 hours is an exclusion.
- •Recent (<12 hours) parenteral GPIIb/IIIa antagonist.
- •Recent (<1 hour) thrombolysis. If the ICH has occurred between 1 and 12 hours following thrombolysis, cryoprecipitate (1U per 10kg) and tranexamic acid must be administered prior to treatment.
- •Participation in any investigational study in the last 30 days
- •Pregnant women (clinically evident)
- •Co-morbidities or advance care directive preventing general anaesthesia for the procedure.
- •Known terminal illness such that the patients would not be expected to survive a year.
- •Planned withdrawal of care or comfort care measures.
- •Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
结局指标
主要结局
Dichotomized Modified Rankin Scale Score 0-3 vs. 4-6 at 6 months post-onset (Adjusted)
时间窗: 6 months post-stroke
Modified Rankin Scale (mRS) 0-3 at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume.
次要结局
- Proportion of patients with early neurological improvement at 7 days (adjusted)(7 days post-stroke)
- Dichotomized Modified Rankin Scale Score 0-2 or no change from baseline vs. 3-6 at 6 months post-onset (adjusted)(6 months post-stroke)
- Ordinal analysis of Modified Rankin Scale Score at 6 months post-onset (adjusted)(6 months post-stroke)
- Utility-weighted analysis of Modified Rankin Scale Score at 6 months post-onset (adjusted)(6 months post-stroke)
- Reduction in hematoma volume at 24 hours >70% or <15mL residual volume (adjusted)(24 hours post-randomization)
研究者
Bruce Campbell
Professorial Fellow, Department of Medicine, Royal Melbourne Hospital, Faculty of Medicine, Dentistry and Health Sciences
University of Melbourne