Research sheds light on brain haemorrhage risk after stroke treatment
June 2016: Jointly led CCBS research published today in Lancet Neurology provides more information about the risks of cerebral haemorrhage in people given alteplase after a stroke.
In patients presenting to hospital with an acute ischaemic stroke, the drug alteplase can dissolve (or ‘lyse’) the clot responsible. Randomised trials have previously shown that, if given within about 4.5 hours of the onset of symptoms, alteplase increases the proportion of patients who are free of disability by 3 months, with larger benefits the earlier that alteplase restores the brain’s blood supply (ie, ‘time is brain’).
In a small proportion of patients, however, alteplase causes major bleeding into the brain (cerebral haemorrhage), which usually results in serious disability or death.
New research reported in Lancet Neurology today now provides better information about the risks of cerebral haemorrhage in patients given alteplase after acute stroke.
The research provides valuable new information that will help doctors who treat patients with acute stroke.
Although on average the benefits of alteplase exceeded its risks, our research showed that the precise balance of benefit and risk for a particular patient was dependent not only on how quickly they were treated but also on the severity of the stroke, since the risks of cerebral haemorrhage were larger in more severe strokes.
When a person arrives in hospital after a stroke, doctors need to be able to predict rapidly both the expected reduction in disability from alteplase and the risk of cerebral haemorrhage, and then to discuss with patients and their families or carers whether the treatment is appropriate.
This new research is important because it shows that, when given within 4.5 hours, the balance of benefit and risk with alteplase is favourable.
The new research helps to address public concerns about the safety of alteplase. In 2014 the UK Medicines and Healthcare products Regulatory Authority announced a review of the evidence by an Expert Working Group, which reported its findings in 2015. It found that alteplase is safe and effective when used within the terms of the product licence.
Related links
Read the publication in Lancet Neurology
Brain vascular disease research at CCBS
Dr William Whiteley Principal Investigator profile
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