Role of Citicoline and Cerebrolysin combination in the management of severe traumatic brain injury: A Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Serum Neuron-Specific Enolase (NSE) levels
研究概览
简要总结
This is a prospective randomized study designed to evaluate the role of citicoline and cerebrolysin in patients with severe traumatic brain injury. Adult patients aged 18 to 65 years with severe traumatic brain injury will be randomized into two groups. One group will receive citicoline and cerebrolysin in addition to standard intensive care management while the control group will receive standard intensive care management. Neurological outcome will be assessed using Glasgow Coma Scale and Glasgow Outcome Scale during hospital stay. The study aims to compare neurological recovery and clinical outcomes between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged 18 to 65 years with severe traumatic brain injury defined as Glasgow Coma Scale less than or equal to 8, admitted within 24 hours of injury, with CT scan evidence of traumatic brain injury, requiring intensive care management.
排除标准
- •Postoperative TBI; NCCT evidence of midline shift or herniation; pre-existing renal/hepatic failure; pregnancy; known hypersensitivity to Citicoline or Cerebrolysin.
结局指标
主要结局
Change in Serum Neuron-Specific Enolase (NSE) levels
时间窗: Baseline (Day 0), Day 7, and Day 14.
次要结局
- Improvement in Glasgow Coma Scale (GCS) score(Daily from Admission to Day 14.)
- Functional outcome via Glasgow Outcome Scale (GOS).(At discharge and 3-month follow-up)
- Total Length of Hospital Stay and 14-day Mortality.(During hospital stay.)
研究者
OBILI Manoj
King Georges Medical University, Lucknow