Lycopene Following Aneurysmal Subarachnoid Haemorrhage
- Registration Number
- NCT00905931
- Lead Sponsor
- University of Cambridge
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 124
Inclusion Criteria
- Age: > 18 years old,
- Confirmed aneurysmal subarachnoid hemorrhage (aSAH),
- Time from ictus < 96 hours
Exclusion Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo - Active Lycopene -
- Primary Outcome Measures
Name Time Method Incidence of vasospasm 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 Daily for 21 days Transient hyperaemic response test; Mx
- Secondary Outcome Measures
Name Time Method Level of biochemical markers of vascular injury: LDL, oxy-LDL, CRP, circulating endothelial cells, endothelial progenitor cells Days: 0, 3, 6, 12, 14, 21
Trial Locations
- Locations (1)
Addenbrooke's Hospital
🇬🇧Cambridge, Cambridgeshire, United Kingdom