ACTRN12618001371280尚未招募2 期
A randomised double blind placebo control trial of the efficacy of oral N-acetyl Cysteine in mild traumatic brain injury patients presenting to a regional Emergency Department
MDHB0 个研究点目标入组 120 人开始时间: 2018年8月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 17 Years 至 o limit（—）
- 性别
- All
入选标准
- •>16 years old
- •head injury or significant deceleration injury t o torso with at least one of the following
- •Confusion or disorientation
- •Loss of consciousness Post trauma amnesia
- •other neurological abnormality - focal signs seizure intracranial lesion on CT
排除标准
- •moderate or severe TBI (GCS <13 on ED arrival, Post traumatic amnesia >24h)
- •-need for hospital admission for any reason (due to the logistics of the study)
- •-Not living independantly
- •-Unable to take NAC for any reason
- •-Non resident in the area/ not able to follow up at 7 days
- •-Significant intoxication with alcohol or other drug (if patient is sober and able to provide informed consent at the time of discharge and otherwise meets study criteria, they are eligible for the study)
- •-Known cognitive impairment
研究者
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