European multicentre, randomised, phase III clinical trial of therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke
To determine whether systemic cooling to a target body temperature between 34.0 and 35.0°C, started within 6 hours of symptom onset and maintained for 24 hours, improves functional outcome at 3 months in patients with acute ischaemic stroke.
Chief Investigator: Prof. Dr. med. Dr. h.c. Stefan Schwab
Number and location of participating sites (by region/ country): Currently Centres in Germany, Belgium, Denmark, UK, France, Italy, Spain and Turkey
Funder: Seventh Framework Programme (FP7) of the European Union (Grant Agreement no. 278709).
Start and End date of grant award of recruitment: July 2013 - March 2017
Current Status: awaiting publication
Trial Unblinding Information: Unblinding will only happen after all analyses are finalised and two unbiased conclusions have been written, one assuming that one group is the hypothermia group and the other assuming that the same group is the normothermia group.
Contact details : University Hospital Erlangen
Represented by the Dean at Medical Faculty, Friedrich-Alexander-Universität Erlangen-Nürnberg, Maximiliansplatz 2, 91054 Erlangen
ECTU Involvement: eCRF and Database