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

Van Der Worp HB, Macleod MR, Bath PMW, Demotes J, Durand-Zaleski I, Gebhardt B, Gluud C, Kollmar R, Krieger DW, Lees KR, Molina C, Montaner J, Roine RO, Petersson J, Staykov D, Szabo I, Wardlaw JM, Schwab S (2014)

Publication Type: Journal article

Publication year: 2014

Journal

International Journal of Stroke Wiley-Blackwell

Publisher: Wiley-Blackwell

Book Volume: 9

Pages Range: 642-5

Journal Issue: 5

DOI: 10.1111/ijs.12294

Abstract

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

Authors with CRIS profile

Dimitre Staykov Medizinische Fakultät Stefan Schwab Lehrstuhl für Neurologie

Involved external institutions

University Medical Centre Utrecht (UMC Utrecht) NL Netherlands (NL) University of Edinburgh GB United Kingdom (GB) University of Nottingham GB United Kingdom (GB) National Institute for Health and Medical Research / Institut national de la santé et de la recherche médicale (INSERM) FR France (FR) Centre hospitalier universitaire Henri-Mondor (CHU Henri-Mondor) FR France (FR) Copenhagen University Hospital DK Denmark (DK) Klinikum Darmstadt DE Germany (DE) University of Glasgow GB United Kingdom (GB) Vall d'Hebron University Hospital / Hospital Universitari Vall d'Hebron ES Spain (ES) Turku University Hospital / Turun yliopistollinen keskussairaala (TYKS) FI Finland (FI) Skåne University Hospital / Skånes universitetssjukhus SE Sweden (SE) European Stroke Research Network for Hypothermia (EuroHYP-1) BE Belgium (BE)

How to cite

APA:

Van Der Worp, H.B., Macleod, M.R., Bath, P.M.W., Demotes, J., Durand-Zaleski, I., Gebhardt, B.,... Schwab, S. (2014). 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. International Journal of Stroke, 9(5), 642-5. https://doi.org/10.1111/ijs.12294

MLA:

Van Der Worp, H. Bart, et al. "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." International Journal of Stroke 9.5 (2014): 642-5.

BibTeX: Download