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Eur Stroke J. 2019 Sep;4(3):254-262. doi: 10.1177/2396987319844690. Epub 2019 Apr 20.

Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicentre, randomised, phase III clinical trial.

Author information

1
Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands.
2
Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, Scotland, UK.
3
Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.
4
Stroke Department, Northwick Park Hospital, London, UK.
5
Department of Neurology, Bispebjerg og Frederiksberg Hospitaler, University of Copenhagen, Copenhagen, Denmark.
6
University of Lille, Inserm U1171, Degenerative and Vascular Cognitive Disorders, Centre Hospitalier Universitaire Lille, Lille, France.
7
ECRIN, Paris, France.
8
APHP URCEco, University Paris Est Creteil & INSERM UMR 1123, Paris, France.
9
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
10
Department of Cardiology, Holbæk Hospital, Copenhagen, Denmark.
11
Department of Neurology, University Medical Centre Erlangen, Erlangen, Germany.
12
Klinik für Neurologie und Neurointensivmedizin, Klinikum Darmstadt, Darmstadt, Germany.
13
Mediclinic Middle East, Dubai, UAE.
14
School of Medicine, Dentistry & Nursing, University of Glasgow, Glasgow, UK.
15
Department of Neurology, University of Leipzig, Leipzig, Germany.
16
Hospital Universitari Vall d´Hebron, Barcelona, Spain.
17
Neurovascular Research Laboratory, Vall d'Hebron Research Institute, Barcelona, Spain.
18
Division of Clinical Neurosciences, Turku University Hospital and University of Turku, Turku, Finland.
19
Department of Neurology, Skane University Hospital, Malmö, Sweden.
20
Stroke Service, National Hospital for Neurology & Neurosurgery, Queen Square, London, UK.
21
Department of Neurology, Hospital of the Brothers of St. John, Eisenstadt, Austria.
22
European Stroke Research Network for Hypothermia, Brussels, Belgium.
23
AZ Sint-Jan Brugge-Oostende, Brugge, Belgium AV.
24
Edinburgh Imaging, Centre for Clinical Brain Sciences and UK Dementia Research Institute, University of Edinburgh, Edinburgh, UK.

Abstract

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.

KEYWORDS:

Ischaemic stroke; cooling; hypothermia; randomised trial; treatment

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