European research is launched into hypothermia stroke treatmentBMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e2215 (Published 20 March 2012) Cite this as: BMJ 2012;344:e2215
A major phase III clinical trial of mild hypothermia to treat stroke patients by cooling the brain will be launched later this year after the consortium involved secured funding of some €11m (£9.2m; $14.5m) from the European Commission’s research programme.
The five year trial, called EUROHYP-1, will begin in November when 60 hospitals in 25 countries will use the technique to treat 1500 patients who have had an acute ischaemic stroke. It has already been tested in over 200 animal experiments and in pilot clinical trials involving around 100 volunteers. These have shown that cooling the brain within six hours of a stroke can be remarkably effective in saving patients and reducing brain damage.
Malcolm Macleod, head of experimental neuroscience at the Centre for Clinical Brain Sciences at the University of Edinburgh, has worked for the past four to five years with colleagues in Erlangen (Bavaria), Copenhagen, Malmö, Utrecht, and Glasgow to bring together an international consortium with the necessary expertise for the trial.
Speaking at the presentation of the trial in Brussels on 19 March, he said, “Our job is to show with certainty by 2017 whether this treatment can work.” With 1000 people dying from stroke every day in Europe, he added that the researchers estimate that hypothermia could improve the outcome for more than 40 000 Europeans each year.
Therapeutic hypothermia is already used effectively to reduce ischaemic brain injury after cardiac arrest and birth injuries. It induces a form of hibernation and minimises the need for oxygen, preventing further damage. Similar equipment could be used for stroke patients; and Bart van der Worp, of the University Medical Centre in Utrecht, confirmed that a patient could be cooled to the requisite 34°C to 35°C within one hour, with the treatment lasting for 24 hours.
Patients who undergo therapeutic cooling will also be eligible for all the usual treatments for stroke, including tissue plasminogen activator, Dr Macleod told the BMJ.
The trial would focus on patients who can be treated in hospital within six hours of a stroke. This is considered a critical timeframe for increasing the chances of a successful outcome. However, that target is far from being reached in Europe. In France only 5% of patients reach hospital within four hours of a stroke, while in the United Kingdom and Sweden the figure is around 20% within three hours.
Jesper Petersson, of the neurology department at Lund University, Sweden, noted that the treatment was extremely safe, the only side effects being shivering and some discomfort, which could be controlled with drugs, and possible vulnerability to infections.
The trial, which follows from a pilot study funded by Chest Heart & Stroke Scotland, is being led by Erlangen University Clinic and the European Stroke Research Network for Hypothermia (EuroHyp (www.Eurohyp.org)). It involves a strong Scottish input, with the data management and image analysis platforms being located in Edinburgh and the outcome assessment taking place in Glasgow.
Cite this as: BMJ 2012;344:e2215