Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicentre, randomised, phase III clinical trial
van der Worp, H. B. (Department of Neurology and Neurosurgery. Brain Center. University Medical Center Utrecht)
Macleod, Malcolm R. (Centre for Clinical Brain Sciences. University of Edinburgh)
Bath, P. M. W. (Stroke Trials Unit. Division of Clinical Neuroscience. University of Nottingham)
Bathula, R. (Stroke Department. Northwick Park Hospital)
Christensen, Hanne (University of Copenhagen)
Colam, B. (Centre for Clinical Brain Sciences. University of Edinburgh)
Cordonnier, Charlotte (University of Lille. Inserm U1171. Degenerative and Vascular Cognitive Disorders. Centre Hospitalier Universitaire Lille)
Demotes-Mainard, J. (ECRIN)
Durand-Zaleski, I. (APHP URCEco. University Paris Est Creteil & INSERM. UMR 1123)
Gluud, C. (Copenhagen Trial Unit. Centre for Clinical Intervention Research. Rigshospitalet. Copenhagen University Hospital)
Jakobsen, J. C. (Holbæk Hospital (Dinamarca))
Kallmünzer, B. (Department of Neurology. University Medical Centre Erlangen)
Kollmar, R. (Klinik für Neurologie und Neurointensivmedizin. Klinikum Darmstadt)
Krieger, D. W. (Mediclinic Middle East)
Lees, K. R. (School of Medicine. Dentistry & Nursing. University of Glasgow)
Michalski, D. (Department of Neurology. University of Leipzig)
Molina, Carlos (Hospital Universitari Vall d'Hebron)
Montaner, Joan (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Roine, R. O. (Turku University Hospital (Finlàndia))
Petersson, J. (Skåne University Hospital (Suècia))
Perry, Richard (Stroke Service. National Hospital for Neurology & Neurosurgery)
Sprigg, N. (Stroke Trials Unit. Division of Clinical Neuroscience. University of Nottingham)
Staykov, D. (Department of Neurology. Hospital of the Brothers of St. John)
Szabo, I. (European Stroke Research Network for Hypothermia)
Vanhooren, G. (AZ Sint-Jan Brugge-Oostende)
Wardlaw, J. M. (Edinburgh Imaging. Centre for Clinical Brain Sciences. UK Dementia Research Institute. University of Edinburgh)
Winkel, P. (Copenhagen Trial Unit. Centre for Clinical Intervention Research. Rigshospitalet. Copenhagen University Hospital)
Schwab, S. (Department of Neurology. University Medical Centre Erlangen)
Universitat Autònoma de Barcelona

Data:	2019
Resum:	Introduction: We assessed whether modest systemic cooling started within 6 hours of symptom onset improves functional outcome at three months in awake patients with acute ischaemic stroke. Patients and methods: In this European randomised open-label clinical trial with blinded outcome assessment, adult patients with acute ischaemic stroke were randomised to cooling to a target body temperature of 34. 0-35. 0°C, started within 6 h after stroke onset and maintained for 12 or 24 h, versus standard treatment. The primary outcome was the score on the modified Rankin Scale at 91 days, as analysed with ordinal logistic regression. Results: The trial was stopped after inclusion of 98 of the originally intended 1500 patients because of slow recruitment and cessation of funding. Forty-nine patients were randomised to hypothermia versus 49 to standard treatment. Four patients were lost to follow-up. Of patients randomised to hypothermia, 15 (31%) achieved the predefined cooling targets. The primary outcome did not differ between the groups (odds ratio for good outcome, 1. 01; 95% confidence interval, 0. 48-2. 13; p = 0. 97). The number of patients with one or more serious adverse events did not differ between groups (relative risk, 1. 22; 95% confidence interval, 0. 65-1. 94; p = 0. 52). Discussion: In this trial, cooling to a target of 34. 0-35. 0°C and maintaining this for 12 or 24 h was not feasible in the majority of patients. The final sample was underpowered to detect clinically relevant differences in outcomes. Conclusion: Before new trials are launched, the feasibility of cooling needs to be improved.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	European Stroke Journal, Vol. 4 Núm. 3 (january 2019) , p. 254-262, ISSN 2396-9881

DOI: 10.1177/2396987319844690
PMID: 31984233

9 p, 267.6 KB

El registre apareix a les col·leccions:
Articles > Articles de recerca
Articles > Articles publicats