intracerebral haemorrhage
Conditions
Interventions
Patients will be randomised via a 24-hour central internet-based randomisation
system (or IVRS system,
currently in development) to either (a) intensive or (b) conservative
management of BP. Treatme
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: a. 18 years or older. b. Acute stroke due to sponataneous ICH, confirmed by clinical history and CT scan. c. At least 2 separate blood pressure measurements of systolic blood pressure >=150 mmHg, and
Exclusion criteria
Exclusion criteria: a. Known definite contraindication to an intensive BP lowering regimen (eg severe carotid, vertebral or cerebral arterial stenosis, known Moya Moya disease or Takayasu*s arteritis, high-grade stenotic valvular heart disease, or severe renal failure). b. Known definite indication for an intensive BP lowering regimen that is similar or more intensive than the active treatment arm of this study (eg very high systolic BP >220 mmHg, hypertensive encephalopathy, or aortic dissection). c. 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. d. Previous ischaemic stroke within 30 days. e. A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria (eg massive haematoma with mid-line shift of hemisphere or deep coma on presentation, defined by Glasgow Coma Scale Score of 3-5), (NB seizures occur commonly after the onset of ICH, so a reduction in the level of consciousness that isdisproportionate to the size of the haematoma may be secondary to epilepsy rather than mass effect from the ICH). f. Known advanced dementia or significant pre-stroke disability (eg modified Rankin Score [mRS] of 3 or more). g. Concomitant medical illness that would interfere with outcome assessments and follow-up (eg advanced cancer or respiratory disease). h. Already booked for surgical evacuation of haematoma. i. Previous participation in this trial or current participation in an investigational drug trial. j. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: the efficacy of the treatment regime will be evaluated on the combined endpoint of death and dependency at the end of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary outcome: to assess efficacy of the primary outcome in those patients treated within 4 hours of ICH onset. Other secondary outcomes: to determine effects of treatment on (a) physical function, health-related quality of life, recurrent stroke and other vascular events, days of hospitalisation, and requirement for permanent residential care, and (b) other serious adverse events. | — |
Countries
Netherlands
Outcome results
None listed