Lycopene following aneurysmal subarachnoid haemorrhage (LASH)
Research type
Research Study
Full title
Acute oral lycopene therapy to improve autoregulation prevent delayed cerebral ischaemia following aneurysmal subarachnoid haemorrhage: A randomised controlled trial (LASH trial)
IRAS ID
25037
Contact name
Peter J Kirkpatrick
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Research summary
Delayed ischaemic deficits (a kind of second stroke that happens usually between 4 and 14 days after a bleed) are one of major causes of poor outcome following aneurysmal subarachnoid haemorrhage (bleeding on the surface of the brain from a ruptured aneurysm – a blister on a vessel). Mechanisms are complex and include inflammation of brain vessels, programmed cell death of the inner lining of the vessels, accumulation of oxidized, harmful cholesterols, and small clots which may become embolic material. Delayed cerebral ischaemia is often a result of disruption of the normal self-protection mechanisms of brain’s circulation (impaired autoregulation) and narrowing of cerebral vessels (vasospasm). Early detection of vasospasm and impaired autoregulation can be measured non-invasively by use of transcranial Doppler (TCD) ultrasonography and transient hyperaemic response test (THRT). In this study we wish to explore potential protective effects of supplementing lycopene, a natural anti-oxidant obtained from tomatoes, on cerebral autoregulation and vasospasm, and to see if the observed changes cause a reduction of biochemical and physical markers of vascular injury and inflammation. 124 adults following aneurysmal subarachnoid haemorrhage will be recruited (within 96 hours of the bleed) over two years. They will receive daily 30 mg of lycopene or placebo for 21 days as part of a randomized, double-blind, placebo-controlled study. Every day we will perform a TCD assessment to detecting vasospasm and impaired autoregulation. The main outcome of the study will be the severity and duration of impairments in cerebral autoregulation and number of patients who will have cerebral vasospasm. Other outcomes will include the presence of biological physical markers of vascular injury. Results, will be used in potential designing of further studies with clinical endpoints.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
14/EE/0013
Date of REC Opinion
9 Apr 2014
REC opinion
Further Information Favourable Opinion