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

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@article{05771fa98159489cab051c7036626904,
title = "Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicentre, randomised, phase III clinical trial",
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.",
author = "{van der Worp}, {H Bart} and Macleod, {Malcolm R} and Bath, {Philip Mw} and Raj Bathula and Hanne Christensen and Bridget Colam and Charlotte Cordonnier and Jacques Demotes-Mainard and Isabelle Durand-Zaleski and Christian Gluud and Jakobsen, {Janus Christian} and Bernd Kallm{\"u}nzer and Rainer Kollmar and Krieger, {Derk W} and Lees, {Kennedy R} and Dominik Michalski and Carlos Molina and Joan Montaner and Roine, {Risto O} and Jesper Petersson and Richard Perry and Nikola Sprigg and Dimitre Staykov and Istvan Szabo and Geert Vanhooren and Wardlaw, {Joanna M} and Per Winkel and Stefan Schwab and {EuroHYP-1 investigators}",
note = "{\circledC} European Stroke Organisation 2019.",
year = "2019",
month = "9",
doi = "10.1177/2396987319844690",
language = "English",
volume = "4",
pages = "254--262",
journal = "European Stroke Journal",
issn = "2396-9873",
publisher = "SAGE Publications Inc.",
number = "3",

}

RIS

TY - JOUR

T1 - Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicentre, randomised, phase III clinical trial

AU - van der Worp, H Bart

AU - Macleod, Malcolm R

AU - Bath, Philip Mw

AU - Bathula, Raj

AU - Christensen, Hanne

AU - Colam, Bridget

AU - Cordonnier, Charlotte

AU - Demotes-Mainard, Jacques

AU - Durand-Zaleski, Isabelle

AU - Gluud, Christian

AU - Jakobsen, Janus Christian

AU - Kallmünzer, Bernd

AU - Kollmar, Rainer

AU - Krieger, Derk W

AU - Lees, Kennedy R

AU - Michalski, Dominik

AU - Molina, Carlos

AU - Montaner, Joan

AU - Roine, Risto O

AU - Petersson, Jesper

AU - Perry, Richard

AU - Sprigg, Nikola

AU - Staykov, Dimitre

AU - Szabo, Istvan

AU - Vanhooren, Geert

AU - Wardlaw, Joanna M

AU - Winkel, Per

AU - Schwab, Stefan

AU - EuroHYP-1 investigators

N1 - © European Stroke Organisation 2019.

PY - 2019/9

Y1 - 2019/9

N2 - 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.

AB - 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.

U2 - 10.1177/2396987319844690

DO - 10.1177/2396987319844690

M3 - Journal article

VL - 4

SP - 254

EP - 262

JO - European Stroke Journal

JF - European Stroke Journal

SN - 2396-9873

IS - 3

ER -

ID: 59134380