Status:
COMPLETED
The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial
Lead Sponsor:
The George Institute
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Conditions:
Intracerebral Hemorrhage
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated bl...
Detailed Description
Intracerebral haemorrhage (ICH) is one of the most serious subtypes of stroke, affecting over a million people worldwide each year, most of whom live in Asia. About one third of people with ICH die ea...
Eligibility Criteria
Inclusion
- Patients with CT-confirmed spontaneous Intracerebral Haemorrhage (ICH)
- Elevated systolic blood pressure (\>150mmHg and \<220mmHg)
- Capacity to commence randomly assigned treatment within 6 hours of onset of ICH.
- Able to be 'actively' treated and admitted to a monitored facility
Exclusion
- Clear indication or contraindication to intensive BP lowering.
- Evidence ICH secondary to a structural abnormality
- Use of thrombolytic agent
- 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
- Score of 3-5 on the Glasgow Coma Scale (indicating deep coma)
- Significant pre-stroke disability or advanced dementia
- Planned early neurological intervention
- Participation in another clinical trial.
- A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
2839 Patients enrolled
Trial Details
Trial ID
NCT00716079
Start Date
September 1 2008
End Date
December 1 2012
Last Update
December 13 2013
Active Locations (62)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Regional Coordinating Centre Argentina
Buenos Aires, Argentina
3
Canberra Hospital
Canberra, Australian Capital Territory, Australia, 2605
4
Concord Hospital
Concord, New South Wales, Australia, 2138