An investigator initiated international, multicentre, stepped wedge cluster randomised study of a care bundle of physiological control strategies in acute intracerebral haemorrhage patients in comparison to usual care
- Conditions
- Acute spontaneous intracerebral haemorrhage
Recruitment & Eligibility
- Status
- Complete: follow up continuing
- Sex
- Not specified
- Target Recruitment
- Not specified
•Age >= 18 (both male and female)
•Acute stroke syndrome that is due to presumed spontaneous ICH, confirmed by clinical history and a CT scan within 6 hours of stroke onset without/without contrast, and if an CT angiogram is also undertaken as part of routine care.
•Presentation to hospital within 6 hours of stroke onset
•Definite evidence that the ICH is secondary to a structural abnormality in the brain (eg an AVM, intracranial aneurysm, tumour, trauma, or previous cerebral infarction) or previous thrombolysis.
•A high likelihood that the patient will not adhere to the study treatment and follow-up regimen. In each case, the decision about the patient’s eligibility will be based on the attending clinician’s interpretation of the above eligibility criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional recovery according to an ordinal shift analysis of the full range of scores on the modified Rankin scale (mRS) scores at 6 months [6 Months ]<br>
- Secondary Outcome Measures
Name Time Method Functional recovery according to a shift analysis of scores on the National Institutes of Health Stroke Scale (NIHSS) at 7 days. The following at 6-months: poor outcome defined by mRS scores of 3-6; separately on death and disability (mRS 3-5); health-related quality of life (HRQoL) using the EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D); duration of hospitalisation; and residence. [6 months]<br>