NCT00905931Unknown2 期
Acute Oral Lycopene Therapy on Cerebral Autoregulation and Delayed Ischaemic Deficits Following Aneurysmal Subarachnoid Haemorrhage (LASH): A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Incidence of vasospasm
研究概览
简要总结
In this study the investigators wish to explore the potential neuroprotective effects of acute oral supplementation of lycopene, a natural anti-oxidant derived from tomatoes, on cerebral vasospasm and autoregulation, and examine whether any improvements translate into a reduction of biochemical markers of vascular injury and inflammation a decrease in the prevalence of secondary strokes following subarachnoid haemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: > 18 years old,
- •Confirmed aneurysmal subarachnoid hemorrhage (aSAH),
- •Time from ictus < 96 hours
排除标准
- •Age: < 18 years old,
- •Non-aneurysmal SAH,
- •Time from ictus > 96 hours,
- •Severe carotid atherosclerotic disease (≥70%)
- •High-dose statin therapy (>80 mg/day fluvastatin; >40 mg/day simvastatin; >40 mg/day pravastatin; >10 mg/day atorvastatin; >10 mg/day rosuvastatin 28),
- •Allergy or hypersensitivity to tomatoes and tomato products and history of any other significant atopy/allergy (e.g. soy, whey, lutein, lecithin)
研究组 & 干预措施
Active
Experimental
干预措施: Lycopene (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of vasospasm
时间窗: Daily for 21 days
Mean flow velocity in MCA \> 120 cm/min; LR \> 3 (4 if age \< 50 years old)
Duration of impaired autoregulation measured with transcranial Doppler
时间窗: Daily for 21 days
Transient hyperaemic response test; Mx
次要结局
- Level of biochemical markers of vascular injury: LDL, oxy-LDL, CRP, circulating endothelial cells, endothelial progenitor cells(Days: 0, 3, 6, 12, 14, 21)
研究者
研究点 (1)
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