Citicoline Brain Injury Treatment Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,213
- 试验地点
- 8
- 主要终点
- Functional and Cognitive Outcome
研究概览
简要总结
The Citicoline Brain Injury Treatment (COBRIT) is a randomized, double-blind, placebo controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome in patients with complicated mild, moderate and severe traumatic brain injury.
详细描述
Traumatic brain injury (TBI) is a major cause of death and disability. In the United States alone approximately 1.4 million sustain a TBI each year, of which 50,000 people die, and over 200,000 are hospitalized. Despite numerous prior clinical trials no standard pharmacotherapy for the treatment of TBI has been established in either the acute or post acute setting. Citicoline is a naturally occurring endogenous compound. This compound offers the potential of employing neuroprotection, neuro-recovery and neurofacilitation to enhance recovery after TBI.
The primary goal of this study is to assess the efficacy of citicoline compared to placebo on functional and cognitive outcome in participants with traumatic brain injury.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-penetrating traumatic brain injury.
- •Age 18 (19 in Alabama) - 70 years.
- •GCS criteria on/off paralytics as specified in protocol
- •Reasonable expectation of completion of outcomes measures at a network center at six months post-injury.
- •Able to swallow oral medication or, if unable to swallow, a gastric tube or peg are placed by 23 hours after injury.
- •Reasonable expectation of enrollment within 24-hour time window.
- •English-speaking
排除标准
- •Intubated patients with GCS motor score = 6 and not meeting CT criteria.
- •Bilaterally fixed and dilated pupils
- •Positive pregnancy test, known pregnancy, or currently breast feeding
- •Evidence of diseases that interfere with outcome assessment
- •Current acetylcholinesterase inhibitor use (Appendix 1)
- •Imminent death or current life-threatening disease
- •Currently enrolled in another study
研究组 & 干预措施
Placebo
Placebo tablets formulated to resemble the citicoline treatment.
干预措施: Placebo (Drug)
Citicoline
Experimental treatment administered orally or enterally depending upon whether the participant can swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
干预措施: citicoline (Drug)
结局指标
主要结局
Functional and Cognitive Outcome
时间窗: 90 days
The primary outcome of this study was analyzed using a global statistic of the Network Core Battery. There were 9 scales: California Verbal Learning Test II (CVLT-II); Controlled Oral Word Association Test (COWAT); Digit Span (DS); Glasgow Outcome Scale Extended (GOSE); Processing Speed Index (PSI); Stroop Test 1 and 2 (ST1\&2); and Trail Making Test part A and B (TMT parts A and B). Each scale was assigned cut-off for good outcome: GOSE\>7, CVLT\>36, PSI\>85, TMT part A \<42, TMT part B\<138.1, DS\>7.15, ST1\<60.29, ST2\<151.47, COWAT\>32.5. Logistic regression was used to estimate the global OR.
次要结局
未报告次要终点
研究者
William Friedewald
Professor
Columbia University