Potential Impact of Amantadine on Traumatic Brain Injury Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Neuron specific enolase (NSE) ng/mL
研究概览
简要总结
The aim of this study is to evaluate whether the addition of amantadine to the management regimen of traumatic brain injury patients would have a favorable effect on recovery and neurological complications in association with prognosis biomarkers Interleukin-18 (IL-18), Neuron-specific enolase (NSE) and (Neurotensin).
详细描述
Proposal Steps
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
- All participants agreed to take part in this clinical study and provide informed consent.
- Patients will be enrolled if they present with clinical signs of trauma, from Emergency department at Tanta University Hospital
- Complete physical, laboratory, radiological assessment will be done for all patients
- Serum samples will be collected for measuring the biomarkers.
- All enrolled 50 patients will be divided into two groups; Group I are patients who will receive amantadine as added on therapy. Group II are patients who will be managed with the standard regimen.
- All patients will be followed up during 6 weeks period.
- At the end of 6 weeks, prognosis biomarkers will be withdrawn.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Measuring outcome: The primary outcome is to compare the effect of adding amantadine on recovery rate and neurological complications in trauma patients.
- Results, conclusion, discussion and recommendations will be given.
Methodology
- 50 Patients will be randomized equally to the assigned study groups
- Prognosis biomarkers (IL-18, NSE and Neurotensin) will be measured using ELISA
- Conventional routine tests (including renal function tests) will be assessed
- Patients will be evaluated clinically (such as Glasgow score...) for recovery rate for neurological complications.
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, Investigator)
盲法说明
double blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Amantadine Group
Group, I are patients who will receive amantadine (100mg) as add on therapy to the standard regimen.
干预措施: Amantadine (100mg) as add on therapy. (Drug)
Placebo Group
Group II are patients who will be managed with the standard regimen.
干预措施: Placebo (Drug)
结局指标
主要结局
Neuron specific enolase (NSE) ng/mL
时间窗: 2 Weeks
Neuron specific enolase (NSE) by ELISA Kit
Neurotensin pg/ml
时间窗: 2 weeks
Neurotensin pg/ml by ELISA Kit
interleukin-18 (IL-18) pg/ml
时间窗: 2 Weeks
interleukin-18 (IL-18) by ELISA Kit
ICU stay (days)
时间窗: 6 weeks
ICU stay (days)
次要结局
- (GCS) Total Glasgow Coma Scale score: (Severe: GCS 8 or less- Moderate: GCS 9-12- Mild: GCS 13-15).(6 weeks)
- GCS-E(6 months)
研究者
Rehab Werida
Principal Investigator
Damanhour University