试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Lahey Clinic
- 主要终点
- Effectiveness of the NICO BrainPath™ hematoma evacuation system
研究概览
简要总结
The primary objective of this study is to determine the effectiveness of the NICO BrainPath™ hematoma evacuation system for patients between the ages of 18 and 80 years old with an intracerebral hematoma. Effectiveness will be defined as the ability to achieve either 70% reduction of intracranial hematoma or to achieve <15 ml residual hematoma volume following surgery.
Additionally, the study aims to compare the mortality and complication rate of patients who undergo minimally invasive, navigation guided endoport based evacuation of intracerebral hematoma with NICO BrainPath™ System as compared to non-operative, supportive standard of care.
The study is a prospective, non-randomized cohort study. 50 patients will be enrolled in Group A (NICO BrainPath™ system) and 50 patients will be matched retrospectively of similar diagnosis, undergoing standard of care from Epic). 50 patients will undergo minimally invasive, navigation guided endport based evacuation of intracerebral hematoma with NICO BrainPath™ System. The patient population receiving non-operative supportive care will be matched to the surgical patients based on age, gender, and location of hemorrhage.
详细描述
Approximately 100 patients will participate in this study. Patients with significant intraparenchymal hemorrhage who are admitted under the neurology service in the Neurocritical Care and Medical ICU will be screened for eligibility.
A repeat CT scan 6 hours after stabilization to show that there has been no increase in size of the ICH will determine eligibility in the trial. Patients that meet eligibility criteria after this CT will be taken to the OR within 24-72 hours for a minimally invasive, navigation guided endoport based evacuation of the clot using the NICO BrainPath™ system.
At baseline, the Glasgow Coma Scale (GCS) and the Modified Rankin Score (mRS) will be captured, along with baseline demographics. The GCS and mRS will be recorded at 1-, 3, and 6-month post-operatively. A follow-up CT will be captured at 3 months. Mortality and adverse events will be reviewed at each timepoint.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 and 80 years of age, inclusive
- •Spontaneous supratentorial, intracerebral hematoma ICH >30 ml measured by the ABC/2 method.
- •Location of Hemorrhage: Lobar, Putaminal and/or Caudate
- •A Glasgow Coma Scale (GCS) of 4 or greater
- •Historical Modified Rankin Score (mRS) of 0 (no symptoms of neurological disability) or 1 (no significant disability despite symptoms, able to carry out usual duties and activities).
排除标准
- •Pupils dilated and fixed
- •Rapidly deteriorating patient (at the discretion of the surgeon)
- •Primary Thalamic Bleed
- •Intraventricular Blood (more than 50 % of either ventricle, visual estimate)
- •ICH secondary to aneurysm
- •Arteriovenous malformation (AVM)
- •Sinus thrombosis
- •Platelet count <100,000, INR >1.4
- •Known coagulopathy, on anticoagulants that cannot be reversed
结局指标
主要结局
Effectiveness of the NICO BrainPath™ hematoma evacuation system
时间窗: immediately after the surgery.
The primary objective of this study is to determine the effectiveness of the NICO BrainPath™ hematoma evacuation system for patients between the ages of 18 and 80 years old with an intracerebral hematoma. Effectiveness will be defined as the ability to achieve either 70% reduction of intracranial hematoma or to achieve \<15 ml residual hematoma volume immediately after the surgery.
次要结局
- Comparison of mortality and complication rate.(6 months post-op)