van der Worp, H. B. et al. (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), pp. 642-645. (doi: 10.1111/ijs.12294)
Full text not currently available from Enlighten.
Publisher's URL: http://dx.doi.org/10.1111/ijs.12294
Abstract
<b>Rationale</b><p></p> 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.<p></p> <b>Primary aim</b><p></p> 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.<p></p> <b>Design</b><p></p> 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.<p></p> <b>Primary outcome</b><p></p> Score on the modified Rankin Scale at 91 days, as analyzed with ordinal logistic regression and expressed as a common odds ratio.<p></p> <b>Discussion</b><p></p> 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.
Item Type: | Articles |
---|---|
Status: | Published |
Refereed: | Yes |
Glasgow Author(s) Enlighten ID: | Lees, Professor Kennedy |
Authors: | van der Worp, H. B., Macleod, M. R., Bath, P. M. W., Demotes, J., Durand-Zaleski, I., Gebhardt, B., Gluud, C., Kollmar, R., Krieger, D. W., Lees, K. R., Molina, C., Montaner, J., Roine, R. O., Petersson, J., Staykov, D., Szabo, I., Wardlaw, J. M., and Schwab, S. |
College/School: | College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health |
Journal Name: | International Journal of Stroke |
Publisher: | Wiley |
ISSN: | 1747-4930 |
ISSN (Online): | 1747-4949 |
University Staff: Request a correction | Enlighten Editors: Update this record