Clinical trial NCT03324321: Feasibility of Improving Cerebral Autoregulation in Acute Intracerebral Haemorrhage
Official title: Feasibility of Improving Cerebral Autoregulation in Acute Intracerebral Haemorrhage (BREATHE-ICH) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Hemorrhage
Cerebral Brain Hemorrhage
Blood Pressure
Keywords: Cerebral Haemodynamics
Carbon Dioxide
Cerebral Autoregulation
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-centre, prospective, before and after study
Primary purpose: BASIC_SCIENCE

Brief 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). An Autoregulation Index (ARI) can be assigned 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. Dynamic CA (dCA) is a measure of the response of cerebral blood flow (CBF) to rapid changes in blood pressure (BP), and several key studies have shown impaired dCA post-acute ICH. The most recent study demonstrated that dCA impairment lasts up to 12 days. This is particularly important to understand, since our preliminary work has recently shown that changes in carbon dioxide using simple breathing exercises can improve Autoregulation.

Unfortunately, there are limited non-pharmacological management options and significant opportunities to improve patient outcome in ICH. The proposed study addresses this area, by investigating whether a simple breathing exercise in survivors of ICH is safe, feasible and effective in reducing brain injury by improving cerebral autoregulation.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of a haemorrhagic stroke within 48 hours of onset (for patients waking with a stroke, time of onset will be taken to be the time when the patient was last asymptomatic)
* Able and willing to give informed consent
* Male or female, aged 18 years or above
* Able (in the Investigator's opinion) and willing to comply with all study requirements
* Willing to allow his or her General Practitioner (GP) to be notified of participation in the study

Exclusion Criteria:

* Male or Female, aged under 18 years
* Significant previous airways disease (formal diagnosis of moderate or severe airways disease and having treatment for this respiratory condition - via inhalers or specialist input)
* Unable (in the Investigator's opinion) or unwilling to comply with any study requirements
* Female participants who are pregnant, lactating or planning pregnancy during the course of the study
* Clinical diagnosis of stroke greater than 48 hours from onset
* Having had a resolved transient ischaemic attack (TIA) (i.e. neurological symptoms completely resolved upon hospital presentation)
* Co-morbidity with anticipated life expectancy less than 3 months

Primary outcomes:
measure: Post Stroke Morbidity and Mortality
timeFrame: 14 days
measure: The percentage of recruited subjects able to comply with the full measurement protocol
timeFrame: 14 days
measure: The percentage of measurements rejected because of aspects related to data quality during the analysis protocol, with recorded reasons
timeFrame: 14 days
measure: The percentage of recruited subjects in whom values for the following cerebral haemodynamic parameters can be derived
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
Study officials:
affiliation: University of Leicester
name: Thompson G Robinson, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tiecks FP, Lam AM, Aaslid R, Newell DW. Comparison of static and dynamic cerebral autoregulation measurements. Stroke. 1995 Jun;26(6):1014-9. doi: 10.1161/01.str.26.6.1014.
citation: Ma H, Guo ZN, Liu J, Xing Y, Zhao R, Yang Y. Temporal Course of Dynamic Cerebral Autoregulation in Patients With Intracerebral Hemorrhage. Stroke. 2016 Mar;47(3):674-81. doi: 10.1161/STROKEAHA.115.011453. Epub 2016 Feb 4.
citation: Minhas JS, Panerai RB, Swienton D, Robinson TG. Feasibility of improving cerebral autoregulation in acute intracerebral hemorrhage (BREATHE-ICH) study: Results from an experimental interventional study. Int J Stroke. 2020 Aug;15(6):627-637. doi: 10.1177/1747493019873690. Epub 2019 Sep 9.
citation: Minhas JS, Panerai RB, Robinson TG. Feasibility of Improving Cerebral Autoregulation in Acute Intracerebral Haemorrhage (BREATHE-ICH) study: a protocol for an experimental interventional study. BMJ Open. 2018 Mar 27;8(3):e020758. doi: 10.1136/bmjopen-2017-020758.