Status:
UNKNOWN
Lycopene Following Aneurysmal Subarachnoid Haemorrhage
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Cambridge Theranostics Ltd
Conditions:
Subarachnoid Hemorrhage
Aneurysm
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Age: \> 18 years old,
- Confirmed aneurysmal subarachnoid hemorrhage (aSAH),
- Time from ictus \< 96 hours
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00905931
Start Date
September 1 2010
End Date
October 1 2012
Last Update
June 11 2010
Active Locations (1)
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1
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ