The EuroHYP-1 trial is a pan-European, open, randomised, phase III clinical trial which will assess the benefit of therapeutic cooling in adult patients with acute ischaemic stroke. In addition to efficacy and safety, the economic impact of therapeutic hypothermia will be also evaluated.
The EuroHYP consortium brings together leading European experts in statistical design and analysis, therapeutic hypothermia, imaging, health economics, ultrasound, biomarkers, and trial execution (implementation and monitoring) as well as European patient and family advocacy groups and Small and Medium-size Enterprises.
Patient enrolment (28.01.2016)
The EuroHYP-1 trial has been actively recruiting since August 2013. By 28 January 2016, 27 sites were active and 53 patients have been enrolled. By the end of May 2016 the Data and Safety Monitoring Committee (DSMC) will perform a safety interim analysis on the data for the first 50 patients with completed outcome evaluation after 91±14 days post randomisation as per the protocol.