Status:
COMPLETED
Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage
Lead Sponsor:
The George Institute
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Conditions:
CVA (Cerebrovascular Accident)
Cerebral Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of ...
Detailed Description
Intracerebral haemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset ...
Eligibility Criteria
Inclusion
- Aged 18 years or above
- Acute stroke due to spontaneous ICH confirmed by clinical history \& CT scan
- At least 2 systolic BP measurements of \>/=150mmHg and \</=220mmHg, recorded 2 or more minutes apart
- Able to commence randomly assigned BP lowering regimen within 6 hours of stroke onset
- Able to be actively treated and admitted to a monitored facility e.g. HDU/ICU/acute stroke unit
Exclusion
- Known definite contraindication to an intensive BP lowering regimen
- Known definite indication for intensive BP lowering regimen as (or more) intensive than the active treatment arm
- Definite evidence that the ICH is secondary to a structural abnormality in the brain
- Previous ischaemic stroke within 30 days
- A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
- Known advanced dementia or significant pre-stroke disability
- Concomitant medical illness that would interfere with outcome assessments and follow up
- Already booked for surgical evacuation of haematoma
- Previous participation in this trial or current participation in another investigational drug trial
- A high likelihood that the patient will not adhere to the study treatment and follow up regimen
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT00226096
Start Date
November 1 2005
End Date
September 1 2007
Last Update
June 26 2008
Active Locations (20)
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1
Concord Hospital
Concord, New South Wales, Australia, 2138
2
Gosford Hospital
Gosford, New South Wales, Australia, 2250
3
St George Hospital
Kogarah, New South Wales, Australia, 2217
4
John Hunter Hospital
Newcastle, New South Wales, Australia, 2310