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European multicentre, randomised, phase III clinical trial of hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke

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Rehabilitation of ischaemic stroke

Stroke is one of the leading causes of death and disability with limited treatment options even in developed countries. Broad assessment of new approaches is necessary for better management and rehabilitation of stroke patients.

Health

Also referred to as a cerebrovascular accident or cerebrovascular insult, a stroke is the loss of brain function due to a disturbance in blood supply to the brain. This happens as a result of either ischaemia (lack of blood flow) or haemorrhage. The majority of patients have ischaemic stroke (IS), which accounts for about 1.52 million strokes every year in Europe. The EU-funded EUROHYP-1 project is a pan-European randomised, phase III clinical trial. The main goal is to obtain data from the clinical study on the effect of mild hypothermia (34–35 degrees Celsius) for patients with acute IS with treatment started within 6 hours of onset. In addition to efficacy and safety, the economic impact of therapeutic hypothermia will be evaluated and evidence-based recommendations will be formulated. In the first two years the EUROHYP-1 consortium obtained regulatory approval in the first three countries (Denmark, Germany, United Kingdom) and started patient enrolment in Germany. In particular, the group completed and obtained approval of the protocols at the participating units for patient recruitment and delivery of the trial. Patient documentation, which includes an information booklet, surveys about the cooling experience and the patient diary, has been finalised and made available to the participating units in Denmark, Germany and the United Kingdom. During the project's second year partners completed and made available to the participating units components of the data platform, which includes the randomisation platform and reporting system. EUROHYP-1 training efforts include creation of the eLearning platform and coaching followed by certification. A programme for regional investigator hands-on training meetings has been defined and delivered according to the plan implemented by the consortium. Finding of a beneficial effect by the trial will lead to numerous positive outcomes for all stakeholders. Patients and health care providers could thus adopt a new therapeutic strategy, increasing the options available for successful treatment of IS.

Keywords

Ischaemic stroke, clinical trial, therapeutic hypothermia

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