Stroke is the second biggest cause of death worldwide. Among those who survive, it is a major cause of permanent disability. The vast majority of strokes, more than 80%, are “ischaemic” – the result of blood clots preventing blood flow to the brain. Yet treatment options for these strokes are very limited.
EuroHYP-1, a European Union (EU)-funded project which started in early 2012, aims to bring significant new hope to stroke sufferers by carrying out advanced clinical trials of a highly promising new treatment – cooling the patient’s brain. Inducing mild hypothermia puts the brain into a state of hibernation, in which its need for oxygen from the blood is greatly reduced.
“Stroke is a major killer,” says one of the leading researchers in EuroHYP-1, Dr Malcolm Macleod, head of experimental neuroscience at the University of Edinburgh in Scotland. “Every day, 1,000 Europeans die from stroke – that’s one 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.”
Pilot studies have shown that cooling the brains of stroke victims, if carried out within six hours of the stroke, can significantly reduce damage to the brain. EuroHYP-1 will put these initial observations to the test in a pan-European Phase III clinical trial involving 1,500 adult patients with acute ischaemic stroke.
Involving 60 universities and hospitals in 25 different countries, the trial will test the effects of cooling the brain to between 34 and 35°C, compared with normal body temperature of 36.8°C. The five-year trial is due to begin in November 2012. If it is successful, the EuroHYP-1 consortium believes that the cooling technique could lead to 14,700 fewer deaths in Europe and 25,000 more disability-free survivors of stroke.
In view of the substantial economic costs of stroke-related disability, and the relatively modest cost of the cooling treatment itself, it is envisaged that the treatment would not only have a beneficial effect on human health, but would also provide a clear economic benefit as well.
“Based on current evidence, the personal and economic benefits of avoiding stroke-related death and disability mean that the trial would pay for itself in less than a year,” says Professor Stefan Schwab of the Department of Neurology at the Friedrich-Alexander-University Erlangen-Nürnberg in Germany, who is leading the project.
The total cost of EuroHYP-1 is almost €15 million, of which €11 million have been provided under the European Union’s 7th Research Framework Programme (FP7).
In addition to the general reduction of death and disability from strokes that it is hoped it will make possible, therapeutic cooling is expected to be of particular additional benefit for stroke treatment in developing countries, where brain-imaging equipment is not widely available. Unlike other forms of treatment, cooling can be started without waiting for the results of brain-imaging, thus saving vital time in cases where such equipment is not at hand.
Meanwhile, at the other end of the technology spectrum, the European Space Agency is following the trial with close interest because of the possible application of human hibernation techniques in long-haul space travel, and the linkage between this and therapeutic cooling.
As well as involving a large number of medical, statistical and other expert groups, EuroHYP-1 also involves a range of small and medium-sized businesses. These SMEs are developing the necessary new technologies in fields such as cooling, imaging and telemedicine, and the consortium expects this involvement will lead to significant spin-offs in terms of technological innovation and new Research and Development (R&D) capabilities for Europe.