Ischaemic Lesions in Acute Intracerebral Haemorrhage
ConditionIntracerebral Haemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorUniversity of Leicester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
The participants will be recruited from the Leicester Royal Infirmary stroke wards.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Transcranial Doppler ultrasonography (TCD)
DeviceTCD 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Intracerebral Haemorrhage Patients1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrolment to the end of the follow-up (7 days).2
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.
Time frame
From enrolment to the end of the follow-up (7 days).3
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.
Time frame
From enrolment to the end of the follow-up (7 days).4
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.
Time frame
From enrolment to the end of the follow-up (7 days).Secondary outcomes
1
Arterial spin labelling magnetic resonance imaging measurements >7 days post-intracerebral haemorrhage onset.
Absolute values (mL/g/min) in arterial spin labelling magnetic resonance imaging measurements of cerebral blood velocity in response to a respiratory challenge.
Time frame
From enrolment to the magnetic resonance imaging scan (<7 days post-intracerebral haemorrhage onset).2
Arterial spin labelling magnetic resonance imaging measurements >7 days post-intracerebral haemorrhage onset.
Percentage change (%) in arterial spin labelling magnetic resonance imaging measurements of cerebral blood velocity in response to a respiratory challenge (mL/g/min).
Time frame
From enrolment to the magnetic resonance imaging scan (<7 days post-intracerebral haemorrhage onset).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Leicester
Lead sponsor
University Hospitals, Leicester
Collaborator
Source ClinicalTrials.gov