University of Nottingham to study use of tranexamic acid in people with intracerebral haemorrhage

Scientists in Nottingham are leading an international study to investigate the effectiveness of a new treatment on a devastating type of stroke.

The team at The University of Nottingham has been awarded £2.6 million by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme to lead the clinical trial into the use of the drug tranexamic acid in people who have suffered an intracerebral haemorrhage, a type of stroke caused by bleeding in the brain.

Leading the trial, Dr Nikola Sprigg in the University's Division of Stroke, said: "This is potentially very exciting - this drug could offer new hope for a condition for which there is currently no effective treatment.

"If successful, it could potentially improve the lives of thousands of people with haemorrhagic stroke, preventing deaths and reducing disability to increase their chances of leading a full and independent life."

Around 150,000 people in the UK suffer a stroke every year - the majority of these are ischaemic strokes caused by a blocked blood vessel on the brain which can be treated very successfully in many cases with the use of clot-busting drugs (thrombolysis) administered within 4.5 hours of the stroke.

However, 15 per cent of all strokes - affecting around 22,000 people every year - are caused by haemorrhagic stroke when a blood vessel in the brain bursts, leading to permanent damage. Whilst all people with acute stroke benefit from treatment on a stroke unit, there is currently no specific treatment for haemorrhagic stroke and unfortunately many people affected will die within a few days. Those who do survive are often left with debilitating disabilities including paralysis and an inability to speak.

The four-year study will recruit around 2,000 people from 120 hospitals and stroke units, initially across the UK and then worldwide - these will be people who come into hospital as an emergency after suffering from a suspected stroke.

It follows a small pilot study last year, funded by The University of Nottingham and charity the Stroke Association, which concluded that a larger study was needed to accurately assess the effectiveness of the drug tranexamic acid. The drug was chosen for the study after previous research showed that it was successful in stopping bleeding in people involved in road traffic accidents.

For the latest trial, people who are diagnosed as having had bleeding on the brain - confirmed by CT scan -will be offered the chance to take part in the study. Where the person is too ill to decide, permission will be asked of their family.

Half of those who sign up will be given the drug within eight hours of their stroke while half will receive a placebo. The patient's progress will be carefully monitored in hospital over the course of the next seven days and they will receive a second CT scan to see whether the amount of blood on the brain has increased.

The study team will then follow up with the person after three months to assess their recovery, level of disability and how independent they are following their stroke.

The rationale behind giving the treatment so quickly (less than eight hours after stroke onset), is in an attempt to reduce the risk of continued bleeding, therefore potentially reducing the amount of permanent brain damage caused.

The Division of Stroke and Nottingham Stroke Trials Unit, based at Nottingham University Hospitals NHS Trust's City Hospital campus, has an international reputation for clinical and laboratory research in stroke. It also works closely with NHS colleagues in running the nationally-acclaimed clinical stroke service at the hospital.

Recruitment starts this week, initially at 30 UK centres including Nottingham, with further centres across the UK and worldwide expected to join the study in coming months.