A Pilot Study of Ultra-Early Intravenous ɛ-Aminocaproic Acid in Spontanteous Intracerebral Hemorrhage
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Hematoma volume
研究概览
简要总结
This is single-arm, open-label, safety and feasibility pilot study of ɛ-aminocaproic acid in ICH patients.
Consecutive ICH volume with hematoma volume less than 30 mL by ABC/2 method presenting within 3 hours of symptom onset, meeting all inclusion criteria, and without exclusions will be consented and enrolled. Subjects will receive 5 grams of intravenous ɛ-aminocaproic acid over 1 hour, followed by the same at 1 mg/hour for 23 hours. Comupted tomography (CT) head will be done at 24 hours in order to follow hematoma size. Electrocardiogram, lower extremity venous Doppler and NIHSS will also be done at 24 hours. The patient will be followed in the clinic 30-90 days post discharge for functional status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18-80 years
- •Supratentorial ICH ≤ 30 mL in volume and seen on ≥ 2 slices on a 0.5 mm CT head
- •IVH involving < 50% of the ipsilateral lateral ventricle will be allowed
- •Treatment initiated within 1 hour of baseline CT and 3 hours of onset or last known normal
排除标准
- •Baseline mRS ≥ 2
- •Infratentorial hemorrhage (brainstem/cerebellum)
- •Any supratentorial hemorrhage extending to the brainstem
- •ICH > 30 mL
- •Patients who undergo surgical evacuation
- •Presenting outside of the 3 hour window
- •Intraventricular extension > 1/2 of one lateral ventricle
- •Intraventricular extension into the 3rd or 4th ventricle, or the aqueduct or involving >50% of the ipsilateral lateral ventricle
- •ICH due to trauma
- •ICH due to aneurysm of arteriovenous malformation
- •ICH due to underlying neoplasm or infectious mass
- •ICH due to Warfarin or other oral or intravenous anticoagulants
- •International normalization ratio > 1.4
- •Life expectancy < 1 year (prior to ICH onset); due to any cause.
- •History of recent ischemic stroke (within the past 3 months)
- •History of deep vein thrombosis or pulmonary embolism
- •History of recent myocardial infarction (within the past 3 months)
- •Known history of hypercoagulable state
- •History of cancer
- •Glomerular filtration rate < 60 mL/min
- •Received any hemostatic therapy for any indication (last 14 days)
- •Received any investigational therapy in last 90 days
- •"Do Not Resuscitate" order in place or expected, advance directives that could limit aggressive treatment measures.
研究组 & 干预措施
Treatment
Study drug
干预措施: ɛ-Aminocaproic Acid (Drug)
结局指标
主要结局
Hematoma volume
时间窗: 24 hours
National Insitutes of Health Stroke Scale score
时间窗: 24 hours
Lower extermity deep vein thrombosis on venous duplex ultrasound
时间窗: 24-48 hours
Evidence of cardiac ischemia on the electrocardiogram
时间窗: 24 hours
次要结局
- Modified Rankin Scale score(30 Days)