EU project kick-starts groundbreaking global stroke study
An international team of researchers has clinched a near EUR 11 million grant under the Health Theme of the EU's Seventh Framework Programme (FP7) to develop a novel stroke treatment. This groundbreaking, phase 3 clinical study is investigating 1 500 volunteer stroke victims with mild hypothermia. Past pilot studies have found that when the brains of stroke victims are cooled within six hours of their attack, damage to the brain can be reduced. The EUROHYP-1 ('European multicentre, randomised, phase 3 clinical trial of hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke') project partners say this procedure could potentially help thousands of Europeans each year.
Led by the Universitätsklinikum Erlangen in Germany, the EUROHYP-1 consortium is made up of researchers from 36 universities and hospitals across 25 countries.
'A project of this scale would not be possible without a pan-European approach — no one country or smaller group of Member States has yet managed to organise a clinical trial of therapeutic cooling for stroke despite widespread acknowledgement that this is an important and promising therapy,' explains Dr Malcolm Macleod, senior lecturer and head of experimental neuroscience in the Centre for Clinical Brain Sciences at the University of Edinburgh, United Kingdom.
How does therapeutic cooling, or hypothermia, work? It mitigates damage by putting the brain into a kind of hibernation. This helps cut the need for oxygen and stops any further damage from occurring.
The EUROHYP team is helping drive stroke research. 'Stroke is a major killer,' says Dr Macleod. 'Every day 1 000 Europeans die from stroke — that’s 1 every 90 seconds — and about twice that number survive but are disabled. Our estimates are that hypothermia might improve the outcome for more than 40 000 Europeans every year.'
'The challenge now is to recruit in a fairly short time 1 500 patients with acute ischaemic stroke, with particular focus on those who currently do not have access to a truly effective treatment or who exhibit limited response to the existing, standard interventions,' says Professor Stefan Schwab from the Department of Neurology at the Friedrich-Alexander-University Erlangen-Nürnberg in Germany, who has been at the forefront of some pilot hypothermia stroke trials conducted in the past, and now leads the EUROHYP-1 consortium. 'Based on current evidence, the personal and economic benefits of avoiding stroke-related death and disability means that the trial would pay for itself in less than a year. As the population ages, a benefit of cooling demonstrated in the study will set the stage for future studies with hypothermia, extending the eligibility of the treatment to even greater numbers of patients.'
EUROHYP-1 will use cooling data obtained from the phase 2 clinical studies. The team also believes that in the future this groundbreaking treatment could be rolled-out in underdeveloped countries that have little, if any, access to brain imaging tools for stroke care.
Experts estimate stroke cases will number 1.4 million by 2016. If this cooling technique bears fruit, some 350 000 patients could be helped each year. This could lead to 14 700 fewer deaths and 25 000 more disability-free patients following stroke.
The EUROHYP-1 consortium consists of experts from Australia, Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Lithuania, the Netherlands, Poland, Spain, Sweden, Switzerland, Turkey and the United Kingdom.