BREATHE-ICH
Research type
Research Study
Full title
Feasbility of Improving Cerebral Autoregulation in Acute Intracerebral Haemorrhage (BREATHE-ICH)
IRAS ID
230925
Contact name
Thompson G Robinson
Contact email
Sponsor organisation
University of Leicester
Clinicaltrials.gov Identifier
RTF97/0117, Funder Reference (Dunhill Medical Trust)
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
In the UK, 23,000 (15%) of the 150,000 people who suffer a stroke each year have bleeding in the brain, also referred to as acute intracerebral haemorrhage (ICH). ICH has the highest mortality of all stroke subtypes, 40% at 30 days, with half of sufferers dying within a year. Unfortunately, despite being the most devastating form of stroke, it remains the least treatable form with limited therapeutic options.
The ability to maintain an adequate brain blood flow despite sudden changes in blood pressure can be measured in an individual and is referred to as the process of "autoregulation". This control process has been shown to be impaired in acute ischaemic stroke, head injury, in dementia or following premature birth but importantly is associated with worst outcomes for the patient. Cerebral Autoregulation (CA) is assessed using the Autoregulation Index (ARI) which assigns values between 0 and 9 (0 being poor and 9 being the most efficient CA observed) to gauge how good the control over blood flow is at a given time. Several studies have demonstrated that CA impairment lasts up to 12 days in acute ICH. This is particularly important to understand, since our preliminary work has recently shown that changes in carbon dioxide (CO2) using hyperventilation via simple breathing exercises can improve CA. Therefore, this study will examine whether lowering CO2 will improve CA in ICH presenting in first 48 hours and at 10-14 days post event. Study participants will have ultrasound measurements of brain blood flow whilst at rest and during the breathing exercise. The hope is that this novel treatment using a breathing exercise may offer a potential method of improving control of blood flow and importantly prevent complications that cause the significant death rate highlighted above.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
17/EM/0283
Date of REC Opinion
31 Aug 2017
REC opinion
Further Information Favourable Opinion