Lycopene Following Aneurysmal Subarachnoid Haemorrhage
LASH
Acute Oral Lycopene Therapy on Cerebral Autoregulation and Delayed Ischaemic Deficits Following Aneurysmal Subarachnoid Haemorrhage (LASH): A Randomized Controlled Trial
1 other identifier
interventional
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2009
CompletedFirst Posted
Study publicly available on registry
May 21, 2009
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJune 11, 2010
June 1, 2010
1.8 years
May 19, 2009
June 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of vasospasm
Mean flow velocity in MCA \> 120 cm/min; LR \> 3 (4 if age \< 50 years old)
Daily for 21 days
Duration of impaired autoregulation measured with transcranial Doppler
Transient hyperaemic response test; Mx
Daily for 21 days
Secondary Outcomes (1)
Level of biochemical markers of vascular injury: LDL, oxy-LDL, CRP, circulating endothelial cells, endothelial progenitor cells
Days: 0, 3, 6, 12, 14, 21
Study Arms (2)
Active
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age: \> 18 years old,
- Confirmed aneurysmal subarachnoid hemorrhage (aSAH),
- Time from ictus \< 96 hours
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cambridgelead
- Cambridge Theranostics Ltdcollaborator
Study Sites (1)
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Related Publications (1)
Verghese M, Sunkara R, Shackelford L, Walker LT. Lycopene and cardiovascular diseases. In Preedy VR, Watson RR Ed. Lycopene: nutritional, medicinal and therapeutic properties. Science Publishers, New Hampshire, USA 2008.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter J Kirkpatrick, FRCS(SN)
Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Addenbrooke's Hospital, Hills Road, CB2 0QQ Cambridge, UK
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 19, 2009
First Posted
May 21, 2009
Study Start
September 1, 2010
Primary Completion
June 1, 2012
Study Completion
October 1, 2012
Last Updated
June 11, 2010
Record last verified: 2010-06