Validation Of Bioarray In Stroke
Research type
Research Study
Full title
Validation Of Bioarray In Stroke (VOBIS).
IRAS ID
230711
Contact name
Richard Perry
Contact email
Sponsor organisation
Randox Laboratories Ltd
Clinicaltrials.gov Identifier
103026, EDGE ID
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
There are more than 100,000 strokes in the UK every year, and almost two thirds of the survivors leave hospital with disability. Most strokes are caused by a blocked blood vessel (‘ischaemic stroke’) but a few are caused by a burst blood vessel (‘haemorrhagic stroke’). For patients with ischaemic stroke, the outcome can be reduced by giving clot-busting drugs (’thrombolysis’) as soon as possible after the onset of the stroke, and no later than 4.5 hours. Patients whose stroke is caused by blockage of a large artery in the head, a ‘large vessel occlusion’ (LVO), are less likely to benefit from this treatment, but for them the outcome is improved by sucking the clot out through a fine tube fed into the brain from the artery in the groin (‘thrombectomy’).\n\nThere are three challenges to be overcome before these treatments can be delivered effectively. Patients with stroke need to be identified quickly and accurately and taken to a dedicated stroke unit. Among these, patients with ischaemic strokes need to be considered urgently for thrombolysis. Those with strokes caused by an LVO need to be taken directly to a specialist unit which can offer thrombectomy.\n\nThe goal of the current study is to develop a ‘bioarray’ to distinguish these patient groups using a single blood test. The bioarray incorporates multiple immunoassays for biomarkers whose concentration in the blood changes after a stroke. The hypothesis is that the pattern of blood results across the whole array will indicate the diagnosis (ischaemic stroke, haemorrhagic stroke or non-stroke) and for an ischaemic stroke, whether the blockage is in a large vessel. The results will be used to develop a portable analyser which runs all tests simultaneously, yielding results within 15 minutes that can then be used to guide the patient’s management.
REC name
London - South East Research Ethics Committee
REC reference
17/LO/2022
Date of REC Opinion
19 Feb 2018
REC opinion
Further Information Favourable Opinion