An interventional study of Labetalol Hydrochloride and Metoprolol tartrate in CVA (Cerebrovascular Accident), Cerebral Hemorrhage and Intracranial Hemorrhages, sponsored by The George Institute. Completed at 20 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-06-26.
Sponsored by The George Institute · Not applicable, Interventional, and Treatment
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 a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
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 and the majority of survivors are left with major long-term disability. Administration of activated recombinant human Factor VII has been shown to limit haematoma expansion in randomised controlled clinical trials; however, future clinical use of this agent may be limited by a short therapeutic time window, contraindication in patients at risk of thromboembolism and high cost. Currently, no acute medical therapies have been shown to alter outcome in ICH and the role of surgery remains uncertain.
Blood pressure (BP) levels are strongly and positively associated with the incidence of first and recurrent stroke and there is definite evidence that BP lowering reduces stroke risk. Although BP levels are commonly elevated after stroke onset, particularly in ICH, the effects of BP lowering treatment in the acute phase of stroke remain unknown.
The study aims to establish the effectiveness of a management policy of early intensive BP lowering on death \& disability in patients with primary ICH compared to current guideline-based management of high BP in the clinical setting.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 404 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →The George Institute is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Combination death and dependency, according to a 3-6 scores on the modified Rankin Score.
Time frame: 3 months
All cause and cause-specific early neurological deterioration during the first 72 hours; haematoma expansion & cerebral oedema at 24 & 72 hours; ; functional disability; cognitive function; quality of life; mortality at 1 and 3 months
Time frame: 24 and 72 hours, 1 and 3 months
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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