Benefits of Amantadine in Patients With Coma State
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in Glascow Coma Score
研究概览
简要总结
The study was a single center observational-prospective study and approved by local ethics committee. Patients in coma state due to traumatic brain injury, cardiac arrest or ischemic stroke who are older than 18 years of age were included in the study. Patients who received amantadine 200mg/day for fourteen days according to ICU protocols decided by primary physician formed the amantadine group, and the rest of the subjects were included in the control group. All patients were evaluated for Glasgow Coma Score, JFK Coma Recovery Scale and Disability Rating Scale once a week for three months.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years, ≤ 65 years
- •GCS score ≤ 8
- •Coma state due to ischemic stroke, brain hemorhage, anoxic brain damage
排除标准
- •<18 years, > 65 years
- •Patients admitted to the critical care without diagnosis of coma state
- •Patients admitted to critical care with coma state that are not duo to ischemic stroke, brain hemorhage, anoxic brain damage
- •Metastatic malignant neoplazm
- •Congenital or acquired brain function problem (cerebral palsy, autism etc)
- •Patients with amantadine allergy
- •Progressive degenerative diseases (Alzheimer, Parkinson diseases etc)
研究组 & 干预措施
Amantadine group
Patients admitted to the critical care with diagnosis of coma state who have received amantadin 200 mg / day for fourteen days according to İCU protocols decided by primary physician
干预措施: amantadine sulphate (Drug)
结局指标
主要结局
Change in Glascow Coma Score
时间窗: 1. At the time of enrollment 2. 12 weeks after the enrollment
Glascow Coma Score
次要结局
未报告次要终点
研究者
Begum Ergan
Staff in the department of pulmonary and critical care medicine
Dokuz Eylul University