NCT01606111终止4 期
A Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin in Patients With Traumatic Brain Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Composite endpoint of mean score in MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E
研究概览
简要总结
The purpose of this trial is to investigate safety and efficacy of Cerebrolysin as add-on therapy to standard care in patients with acute traumatic brain injury (TBI). The study duration for each patient is 180 days.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Clinical diagnosis of TBI and a GCS 7-12
- •Only isolated TBI
- •Pre-Trauma Karnofsky-Index = 100
- •Age 18-60 years
- •Male and female patients
- •Time to needle for study medication within 6 hours after injury
- •Patient is not pregnant or lactating during the trial and is not of childbearing potential
- •Patient was able to speak, read and write in a pre-defined study language before the accident.
- •Reasonable expectation of completion of outcome measures at follow-up
- •Written informed consent
排除标准
- •Evidence of pre-existing major health problems
- •Any neurological or non-neurological condition independent from TBI that might influence the functional outcome or other efficacy outcome measures
- •Injury of writing hand influencing cognitive or other outcome measures
- •Clear clinical signs of intoxication influencing the evaluation
- •Major drug dependency including alcohol
- •Chronic treatment with steroids, Ca2+-channel blockers or major anticoagulants
- •Penetrating high-velocity missile head trauma
- •Stab wound trauma into the brain
- •Patients with spinal cord injury
研究组 & 干预措施
0.9% NaCl, saline
Placebo Comparator
干预措施: 0.9% NaCl, saline (Drug)
Cerebrolysin
Experimental
干预措施: Cerebrolysin (Drug)
结局指标
主要结局
Composite endpoint of mean score in MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E
时间窗: Day 10
Global status is assessed by an ensemble of appropriate, single efficacy criteria to be tested by a multivariate, directional test approach
Composite endpoint of mean score in PSI, Stroop Color-Word Test, Color Trails Test, Digit Span, Early Reha BI, Finger Tapping Test, MMSE, Hospital Anxiety and Depression Scale, GOS-E
时间窗: Day 90
次要结局
- Mortality(Day 180)
- Composite endpoint of mean score in PSI, Stroop Color-Word Test, Color Trails Test, Digit Span, Early Reha BI, Finger Tapping Test, MMSE, Hospital Anxiety and Depression Scale, GOS-E(Day 180)
研究者
研究点 (1)
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