Ischaemic Lesions in Acute Intracerebral Haemorrhage

NCT06410274 | Recruiting

• 1 other identifier: 0966
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to determine how and why inadequate brain blood flow occurs after bleeding in patients with intracerebral haemorrhage (ICH). Treatment for strokes caused by burst blood vessels involves reducing blood pressure (BP) to stop the bleeding. However, this reduction in BP may affect blood flow, causing blockages in blood vessels within the brain. Fast breathing also affects brain blood flow. Therefore, participants will be asked to undergo a simple brain blood flow assessment using transcranial Doppler (TCD) within 48 hours upon admission to hospital. Patients will then have a follow-up TCD assessment at 4-7 days post-ICH onset, in addition to an MRI scan at \>7 days. This research will help to confirm if blockages after bleeding are caused by reduced blood flow within the brain.

Conditions

Intracerebral Haemorrhage

Keywords

Stroke; Cerebral Autoregulation; Cerebral Blood Flow; Transcranial Doppler; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (4)

• Cerebral blood velocity measurements within 48 hours of admission to hospital and 4-7 days after onset in intracerebral haemorrhage patients.

  Absolute values (cm/s) in cerebral blood velocity measurements in intracerebral haemorrhage patients.

  From enrolment to the end of the follow-up (7 days).

• Cerebral blood velocity measurements within 48 hours of admission to hospital and 4-7 days after onset in intracerebral haemorrhage patients.

  Percentage change (%) in cerebral blood velocity measurements in intracerebral haemorrhage patients.

  From enrolment to the end of the follow-up (7 days).

• End-tidal carbon dioxide measurements within 48 hours of admission to hospital and 4-7 days after onset in intracerebral haemorrhage patients.

  Absolute values (mmHg) in end-tidal carbon dioxide measurements in intracerebral haemorrhage patients.

  From enrolment to the end of the follow-up (7 days).

• End-tidal carbon dioxide measurements within 48 hours of admission to hospital and 4-7 days after onset in intracerebral haemorrhage patients.

  Percentage change (%) in end-tidal carbon dioxide measurements in intracerebral haemorrhage patients.

  From enrolment to the end of the follow-up (7 days).

Secondary Outcomes (2)

• Arterial spin labelling magnetic resonance imaging measurements >7 days post-intracerebral haemorrhage onset.

  From enrolment to the magnetic resonance imaging scan (<7 days post-intracerebral haemorrhage onset).

• Arterial spin labelling magnetic resonance imaging measurements >7 days post-intracerebral haemorrhage onset.

  From enrolment to the magnetic resonance imaging scan (<7 days post-intracerebral haemorrhage onset).

Study Arms (1)

Intracerebral Haemorrhage Patients

Patients with a clinical diagnosis of haemorrhagic stroke on CT imaging 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). This is a non-intervention study so no intervention will be given. However, the investigators will observe changes in cerebral haemodynamics of this group within 48 hours of stroke onset and within 3-7 days post-onset.

Device: Transcranial Doppler ultrasonography (TCD)

Interventions

Transcranial Doppler ultrasonography (TCD) DEVICE

TCD will be used to measure cerebral blood velocity (CBv) in the middle and posterior cerebral arteries (MCA and PCA). Following confirmation of a suitable TCD window, participants will undergo a ten-minute rest period in the supine or semi-supine position. Continuous measurements of CBv, blood pressure (BP), heart rate, and end-tidal carbon dioxide will be recorded. Baseline BP will be measured using an automated BP device prior to each recording to allow calibration of the files offline for analysis. This will occur at the first visit and at follow-up, 4-7 days post-onset of intracerebral haemorrhage.

Intracerebral Haemorrhage Patients

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited from the Leicester Royal Infirmary stroke wards.

You may qualify if:

• Clinical diagnosis of a haemorrhagic stroke on CT imaging 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).
• Male or female, aged 18 years or above.

You may not qualify if:

• MRI imaging is contraindicated or unlikely to tolerate scanning process due to clinical instability (GCS \<8, unable to lie supine).
• Patients requiring anaesthesia.
• Male or Female, aged under 18 years.
• Clinical diagnosis of stroke greater than 48 hours from onset

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Central Study Contacts

Jatinder Minhas, SFHEA

CONTACT

+44 116 252 3299; jm591@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 13, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)