Bath, Philip M.W.

Krieger, D.W.

Lees, Kennedy R.

Macleod, Malcolm R.

Petersson, J.

Schwab, Stefan

Smithson, J.

Sprigg, Nikola

Staykov, D.

van der Worp, H. Bart

Nottingham ePrints

Sprigg, Nikola and Bath, Philip M.W. and Smithson, J. and Lees, Kennedy R. and Macleod, Malcolm R. and van der Worp, H. Bart and Krieger, D.W. and Petersson, J. and Staykov, D. and Schwab, Stefan (2018) A European, multicentre, phase III, clinical trial of hypothermia for acute ischaemic stroke: EuroHYP-1. In: International Stroke Conference 2018, 24-26 Jan 2018, Los Angeles, California, USA. Access from the University of Nottingham repository: http://eprints.nottingham.ac.uk/51084/1/EuroHYP-1%20Abstract%20ISC%2020181.pdfCopyright and reuse: The Nottingham ePrints service makes this work by researchers of the University of Nottingham available open access under the following conditions.This article is made available under the University of Nottingham End User licence and may be reused according to the conditions of the licence.  For more details see: http://eprints.nottingham.ac.uk/end_user_agreement.pdfA note on versions: The version presented here may differ from the published version or from the version of record. If you wish to cite this item you are advised to consult the publisher’s version. Please see the repository url above for details on accessing the published version and note that access may require a subscription.For more information, please contact eprints@nottingham.ac.ukISC 2018  A EUROPEAN, MULTICENTRE, PHASE III, CLINICAL TRIAL OF HYPOTHERMIA FOR ACUTE ISCHAEMIC STROKE: EuroHYP-1  Sprigg N.1, Bath P.M.W.1, Smithson J.1, Lees K2, Macleod M.3, van der Worp H.B.4, Krieger D.W.5, Petersson J.6, Staykov D.7, Schwab S.7 on behalf of the EuroHYP-1 Investigators  1 Division of Stroke, University of Nottingham, UK      2 Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK 3 Centre for Clinical Brain Sciences, University of Edinburgh, UK 4 Department of Neurology, University Medical Centre, Utrecht, The Netherlands 5 Department of Neurology, University of Copenhagen, Denmark 6 Department of Neurology, Malmö, Skane, Sweden 7 Department of Neurology, University of Erlangen, Germany   Background: Cooling is a promising neuroprotective intervention in experimental ischaemic stroke; cooling to 35°C reduced infarct size by about one third. Cooling awake ischaemic stroke patients to 35°C has been shown feasible and safe, but whether this is safe and effective has not been tested in a large clinical trial.2  Aims: To determine whether systemic cooling to target temperature of 34 to 35°C, started within 6 hours of symptom onset and maintained for 12 hours, improves functional outcome at 3 months in patients with acute ischaemic stroke.  Methods:  Open, randomised, phase III, multicentre, international clinical trial with masked outcome assessment testing the safety and efficacy of therapeutic cooling in 800 awake adult patients with acute ischaemic stroke. Cooling will be initiated within 6 hours of symptom onset with an intravenous infusion of 20 ml/kg cooled normal saline (4°C) over 30 to 60 minutes, followed by either surface or endovascular cooling to 34 to 35°C, maintained for 12 hours. Shivering and discomfort will be prevented and treated with anti-shivering drugs. All patients will receive best medical treatment, including alteplase, if indicated. The primary outcome is centrally adjudicated modified Rankin Scale at 90 days (shift analysis). A trial with 400 patients per arm has 80% power to detect a 7% absolute improvement in the mRS at the 5% significance level. As of 23rd October 2017, 87 patients have been recruited across 21 sites in 7 countries.  Conclusion: EuroHYP-1 is ongoing, funded by the European Commission 7th Framework Programme (FP7/2007-2013-278709).      

A European, multicentre, phase III, clinical trial of hypothermia for acute ischaemic stroke: EuroHYP-1

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http://eprints.nottingham.ac.uk/51084/1/EuroHYP-1%20Abstract%20ISC%2020181.pdf

A European, multicentre, phase III, clinical trial of hypothermia for acute ischaemic stroke: EuroHYP-1

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