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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03324321
Recruitment Status : Completed
First Posted : October 27, 2017
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
University of Leicester

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.


Condition or disease Intervention/treatment Phase
Stroke, Acute Hemorrhage Cerebral Brain Hemorrhage Blood Pressure Other: Hypocapnia via Hyperventilation Protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-centre, prospective, before and after study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Feasibility of Improving Cerebral Autoregulation in Acute Intracerebral Haemorrhage (BREATHE-ICH) Study
Actual Study Start Date : October 8, 2017
Actual Primary Completion Date : July 15, 2018
Actual Study Completion Date : July 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Hyperventilation Protocol
This will involve sustained periods of 90-seconds of hyperventilation at two levels (-5mmHg and -10mmHg below baseline EtCO2) to a maximum lower level threshold of EtCO2 24mmHg/CBFV 33cm/s regulated using a metronome. Two-minute washout periods of normal respiration will be allowed between successive measurements. Each incremental reduction in pCO2 will be repeated on two occasions during the same session. Further assessments will be conducted 10-14 days following baseline assessments.
Other: Hypocapnia via Hyperventilation Protocol
90 seconds of hyperventilation using a metronome to lower levels of -5mmHg and -10mmHg below baseline EtCO2




Primary Outcome Measures :
  1. Post Stroke Morbidity and Mortality [ Time Frame: 14 days ]

    Determined using Modified Rankin Scale 0 - No symptoms

    1. - No significant disability, despite symptoms; able to perform all usual duties and activities
    2. - Slight disability; unable to perform all previous activities but able to look after own affairs without assistance
    3. - Moderate disability; requires some help, but able to walk without assistance
    4. - Moderate severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    5. - Severe disability; bedridden, incontinent, and requires constant care 6- Death

  2. The percentage of recruited subjects able to comply with the full measurement protocol [ Time Frame: 14 days ]
  3. The percentage of measurements rejected because of aspects related to data quality during the analysis protocol, with recorded reasons [ Time Frame: 14 days ]
  4. The percentage of recruited subjects in whom values for the following cerebral haemodynamic parameters can be derived [ Time Frame: 14 days ]
    • % 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324321


Locations
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United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Sponsors and Collaborators
University of Leicester
Investigators
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Principal Investigator: Thompson G Robinson, MD, FRCP University of Leicester
Study Data/Documents: Funder  This link exits the ClinicalTrials.gov site
Dunhill RTF Grant (RTF97/0117)

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT03324321    
Other Study ID Numbers: 0624
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Leicester:
Cerebral Haemodynamics
Carbon Dioxide
Cerebral Autoregulation
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Stroke
Intracranial Hemorrhages
Hemorrhage
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases