Effects of Usage of Simvastatin in Mild to Moderate Traumatic Brain Injury (TBI) Patients. Could it Make a Difference?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- 30-day mortality rate
研究概览
简要总结
Traumatic brain injury (TBI) is a common cause of long-term neurological morbidity, with devastating personal and societal consequences. At present, no pharmacological intervention clearly improves outcomes, and therefore a compelling unmet clinical need remains. 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, or "statins," offer a potential novel therapeutic strategy for TBI. In this study the investigators will study primarily the effect of statins on 30-day mortality rate which is defined as death within 30 days of TBI presentation where the occurrence of TBI is hour 0 or day 0 and secondarily evaluation of duration of ICU stay associated with or without complications.
详细描述
TBI is defined as an alteration in brain function, or other evidence of brain pathology, caused by an external force.
[A] Alteration in brain function is defined as 1 of the following clinical signs:
- Any period of loss of or a decreased level of consciousness.
- Any loss of memory for events immediately before (retrograde amnesia) or after the injury (Post traumatic amnesia)
- Neurologic deficits (weakness, loss of balance, change in vision, dyspraxia paresis/plegia [paralysis], sensory loss, aphasia, etc.)
- Any alteration in mental state at the time of the injury (Confusion, disorientation, slowed thinking, etc.) [B] or other evidence of brain pathology: Such evidence may include visual, neuroradiologic, or laboratory confirmation of damage to the brain.
Traumatic brain injury is the most common cause of death and disability in young people.
Traumatic brain injury is graded as mild, moderate, or severe on the basis of the level of consciousness or Glasgow coma scale (GCS) score after resuscitation. Mild traumatic brain injury (GCS 13-15) is in most cases a concussion and there is full neurological recovery, although many of these patients have short-term memory and concentration difficulties. In moderate traumatic brain injury (GCS9-13) the patient is lethargic or stuporous, and in severe injury (GCS 3-8) the patient is comatose, unable to open his or her eyes or follow commands.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients from 18 to 40 years old with mild to moderate TBI
排除标准
- •immunotherapy
- •previous CNs dysfunction
研究组 & 干预措施
Simvastatin
the patient will receive simvastatin 40mg
干预措施: Simvastatin (Drug)
Placebo
the patient will receive placebo drug
干预措施: Placebo drug (Drug)
结局指标
主要结局
30-day mortality rate
时间窗: 30 days
defined as death within30 days of TBI presentation where the occurrence of TBI is hour 0 or day 0.
次要结局
- CBC(30 days)
- 1. ICU stay(30 days)
- Complications(30 days)
- Glasgow Coma Scale (GCS)(30 days)
- CRP(30 days)
研究者
Muhammad Hamdi Taha Muhammad
Principal Investigator , anesthesiology and ICU resident
Assiut University