Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- prognosis of moderate to sever head injury
研究概览
简要总结
Effect of Early Memantine Administration on Outcome of Participents with Moderate to Severe Traumatic Brain Injury
详细描述
Studying the effect of memantine on platelet, platelet/lymphocyte ratio (PLR) and C reactive protein (CRP) & serum NSE levels in participents with moderate to severe TBI as well as outcome.
Investigators evaluate prognostic effect of memantine on participents with moderate to severe TBI. also to estimate which of platelet, platelet/lymphocyte ratio (PLR), C reactive protein (CRP) or serum NSE levels will be affected by administration of memantine in participents with moderate to severe TBI as a predictor of outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Moderate to severe closed TBI with initial GCS of 4-12
- •Age from 18 to 65 years of both sexes
- •Able to tolerate enteral feeding and drug administration within the first 24 hours of TBI.
排除标准
- •Open TBI or patients who would need open craniotomy later on.
- •Comorbid illnesses, such as diabetes mellitus, ischemic heart disease, acute myocardial infarction within the past 48 hours, acute or chronic renal insufficiency, hepatic diseases, autoimmune abnormalities, history of epileptic fits and known malignancies.
- •Patients with chest, cardiac, abdominal trauma or any other trauma requiring mechanical ventilation.
- •Patients with body mass index (BMI) <18.5 or > 34.9 kg/m2.
研究组 & 干预措施
Treatment group (group 2)
in addition to the standard treatment, they will receive memantine (30 mg) twice daily, either orally or through a nasogastric tube for 7 days, starting on the first day of admission to the hospital. The memantine dose administered in our study was based on the maximum dose of 60 mg/day reported in prior human studies
干预措施: Memantine Hydrochloride (Drug)
结局指标
主要结局
prognosis of moderate to sever head injury
时间窗: 7days
Evaluating the effect of memantine administration on the conscious level of patients using the Glasgow coma scale
次要结局
未报告次要终点
研究者
Shady Nemr Youssef
Principal investigator
Minia University