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Rigshospitalet - a part of Copenhagen University Hospital
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EuroHYP-1: European multicenter, randomized, phase III clinical trial of therapeutic hypothermia plus best medical treatment vs. best medical treatment alone for acute ischemic stroke

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  3. European Stroke Organisation (ESO) guidelines for the management of spontaneous intracerebral hemorrhage

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  • H Bart van der Worp
  • Malcolm R Macleod
  • Philip M W Bath
  • Jacques Demotes
  • Isabelle Durand-Zaleski
  • Bernd Gebhardt
  • Christian Gluud
  • Rainer Kollmar
  • Derk W Krieger
  • Kennedy R Lees
  • Carlos Molina
  • Joan Montaner
  • Risto O Roine
  • Jesper Petersson
  • Dimitre Staykov
  • Istvan Szabo
  • Joanna M Wardlaw
  • Stefan Schwab
  • EuroHYP-1 investigators
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RATIONALE: Cooling reduced infarct size and improved neurological outcomes in animal studies modeling ischemic stroke, and also improved outcome in randomized clinical trials in patients with hypoxic-ischemic brain injury after cardiac arrest. Cooling awake patients with ischemic stroke has been shown feasible in phase II clinical trials.

PRIMARY AIM: To determine whether systemic cooling to a target body temperature between 34·0 and 35·0°C, started within six-hours of symptom onset and maintained for 24 h, improves functional outcome at three-months in patients with acute ischemic stroke.

DESIGN: International, multicenter, phase III, randomized, open-label clinical trial with blinded outcome assessment in 1500 patients aged 18 years or older with acute ischemic stroke and a National Institutes of Health Stroke Scale score of 6 up to and including 18. In patients randomized to hypothermia, cooling to a target body temperature of 34-35°C will be started within six-hours after symptom onset with rapid intravenous infusion of refrigerated normal saline or a surface cooling technique and maintained for 24 h with a surface or endovascular technique. Patients randomized to hypothermia will receive pethidine and buspirone to prevent shivering and discomfort.

PRIMARY OUTCOME: Score on the modified Rankin Scale at 91 days, as analyzed with ordinal logistic regression and expressed as a common odds ratio.

DISCUSSION: With 750 patients per intervention group, this trial has 90% power to detect 7% absolute improvement at the 5% significance level. The full trial protocol is available at http://www.eurohyp1.eu. ClinicalTrials.gov Identifier: NCT01833312.

Original languageEnglish
JournalInternational journal of stroke : official journal of the International Stroke Society
Volume9
Issue number5
Pages (from-to)642-5
ISSN1747-4930
DOIs
Publication statusPublished - 15 May 2014

ID: 44295660