ENRICH: A Multi-center, Randomized, Clinical Trial Comparing Standard Medical Management to Early Surgical Hematoma Evacuation Using Minimally Invasive Parafascicular Surgery (MIPS) in the Treatment of Intracerebral Hemorrhage (ICH).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 71
- 主要终点
- Functional Improvement - mRS
研究概览
简要总结
This is a multicenter, randomized, adaptive clinical trial comparing standard medical management to early (<24 hours) surgical hematoma evacuation using minimally invasive parafascicular surgery (MIPS) in the treatment of acute spontaneous supratentorial intracerebral hemorrhage.
详细描述
The ENRICH trial will compare the outcomes between early surgical intervention using the BrainPath® Approach (i.e., MIPS) and a medically managed cohort. The integrated surgical approach includes a combination of available technologies, including the FDA-cleared NICO BrainPath® for non-disruptive access and NICO Myriad® to achieve the goal of maximum clot evacuation. The medically managed cohort will be treated according the Clinical Standardization Guidelines (CSG) as adapted by Emory University from the 2015 AHA/ASA Guidelines for the Management of Spontaneous Intracerebral Hemorrhage. Clinical efficacy will be determined by demonstrating an improvement in functional outcome, as determined by a blinded-assessment of the 180-day utility-weighted modified Rankin Scale (mRS).
Data suggests improved mortality rates and potential functional benefits of surgical ICH evacuation. The methodology proposed for this trial was tested in a preliminary series of 39 patients treated for supratentorial spontaneous ICH and retrospectively reviewed (Labib et al.). These results were replicated in a single center retrospective series of 18 patients (Bauer et al.). Despite positive results of both studies and the widely accepted benefit of the BrainPath Approach (i.e., MIPS) for subcortical lesions, stronger evidence supporting the use of these techniques in ICH is needed for the technique to become universally validated.
CONTACTS:
Sponsor - Primary: Penny Sekerak, MBA, BA, RN (317) 569-1229, Penny.Sekerak@niconeuro.com
Sponsor - Backup: Jennifer Carroll, (317) 709-2466, Jennifer.Carroll@niconeuro.com
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
- •Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH
- •ICH volume between 30 - 80 mL
- •Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. If the actual time of onset is unclear, then the onset will be considered the time that the subject was last known to be well
- •Glasgow Coma Score (GCS) 5 - 14
- •Historical Modified Rankin Score 0 or 1
排除标准
- •Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (<1 year) ICH, as diagnosed with radiographic imaging
- •NIHSS < 5
- •Bilateral fixed dilated pupils
- •Extensor motor posturing
- •Intraventricular extension of the hemorrhage is visually estimated to involve >50% of either of the lateral ventricles
- •Primary Thalamic ICH
- •Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar
- •Use of anticoagulants that cannot be rapidly reversed
- •Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site
- •Uncorrected coagulopathy or known clotting disorder
- •Platelet count < 75,000, International Normalized Ratio (INR) > 1.4 after correction
- •Patients requiring long-term anti-coagulation that needs to be initiated < 5 days from index ICH
- •End stage renal disease
- •Patients with a mechanical heart valve
- •End-stage liver disease
- •History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- •Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or is post-menopausal
- •Known life-expectancy of less than 6 months
- •No reasonable expectation of recovery, Do-Not-Resuscitate (DNR), or comfort measures only prior to randomization
- •Participation in a concurrent interventional medical investigation or clinical trial.
- •Inability or unwillingness of subject or legal guardian/representative to give written informed consent
- •Homelessness or inability to meet follow up requirements
结局指标
主要结局
Functional Improvement - mRS
时间窗: 180 days
Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180-days
次要结局
- Safety - Hemorrhage Volume(24 hours)
- Safety - Procedure-Related Mortality(30 days)
- Economic(30, 90, 120, and 180 days)