The National Institute for Health Research Health Technology Assessment programme in the UK has awarded £2.6 million to a research team at the University of Nottingham to lead an international study of tranexamic acid as a potential treatment for intracerebral haemorrhage, a form of stroke caused by bleeding in the brain.
Patient recruitment for the four-year trial starts this week, initially at 30 UK centres including Nottingham. Further centres across the UK and worldwide are expected to join the study over the coming months.
The plan is to recruit some 2,000 patients in total from 120 hospitals and stroke units. These will be emergency admissions to hospital following a suspected stroke.
Pilot study
Tranexamic acid is an antifibrinolytic agent used to prevent, arrest or reduce unwanted bleeding.
The new trial follows a small pilot study last year, funded by the University of Nottingham and the Stroke Association. It concluded that a larger study was needed accurately to assess the drug’s effectiveness in this setting.
Around 150,000 people in the UK have a stroke every year. The majority of these are ischaemic strokes caused by a blocked blood vessel on the brain.
In many cases they can be treated very successfully with thrombolytics administered within 4.5 hours of the stroke, Nottingham University noted.
However, 15% of all strokes are haemorrhagic, meaning a blood vessel bursts in the brain bursts and causes permanent damage.
Currently there is no specific treatment for haemorrhagic stroke and many of those affected will die within a few days, Nottingham University said. If patients do survive, they are often left with debilitating disabilities, including paralysis and loss of speech.
Study design
In the trial led by the Division of Stroke and Nottingham Stroke Trials Unit, based on the City Hospital campus of Nottingham University Hospitals NHS Trust, people diagnosed with intracerebral haemorrhage will be offered the chance to take part in the study.
Where the affected patient is too ill to decide, consent for participation will be sought from their family.
Half of those who sign up will be given tranexamic acid within eight hours of their stroke, while the other half will receive a placebo.
Each patient’s progress will be monitored in hospital over the next seven days, with a second CT scan to determine whether the amount of blood on the brain has increased.
The study team will then follow up after three months to assess the patient’s recovery, level of disability, and how independent they are following their stroke.
