Feasibility of Improving Cerebral Autoregulation in Acute Intracerebral Haemorrhage

Blood Pressure Clinical Trial

— BREATHE-ICH  

Official title:

Feasibility of Improving Cerebral Autoregulation in Acute Intracerebral Haemorrhage (BREATHE-ICH) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03324321
• Other study ID #: 0624
• Status: Completed
• Phase: N/A
• Start date: October 8, 2017
• Est. completion date: July 15, 2018

Study information

• Verified date: October 2018
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 15, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Cerebral Brain Hemorrhage
• Cerebral Hemorrhage
• Hemorrhage
• Intracranial Hemorrhages
• Stroke
• Stroke, Acute

Intervention

Other:
• Hypocapnia via Hyperventilation Protocol
90 seconds of hyperventilation using a metronome to lower levels of -5mmHg and -10mmHg below baseline EtCO2

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

Tiecks FP, Lam AM, Aaslid R, Newell DW. Comparison of static and dynamic cerebral autoregulation measurements. Stroke. 1995 Jun;26(6):1014-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Stroke Morbidity and Mortality	Determined using Modified Rankin Scale 0 - No symptoms; - No significant disability, despite symptoms; able to perform all usual duties and activities; - Slight disability; unable to perform all previous activities but able to look after own affairs without assistance; - Moderate disability; requires some help, but able to walk without assistance; - Moderate severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; - Severe disability; bedridden, incontinent, and requires constant care 6- Death	14 days
Primary	The percentage of recruited subjects able to comply with the full measurement protocol		14 days
Primary	The percentage of measurements rejected because of aspects related to data quality during the analysis protocol, with recorded reasons		14 days
Primary	The percentage of recruited subjects in whom values for the following cerebral haemodynamic parameters can be derived	% change in CBFv at baseline and in response to a hyperventilation manoeuvre in the acute (<48 hours) and sub-acute (10 to 14 days) periods; Autoregulation index; % change in CBFv at baseline and in response to a hyperventilation manoeuvre in the acute (<48 hours) and sub-acute (10 to 14 days) periods; Autoregulation index	14 days