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

J 2019

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

WORP VAN DER, H. B,, M. R. MACLEOD, P. M. W. BATH, R. BATHULA, H. CHRISTENSEN et. al.

Základní údaje

Originální název

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

Autoři

Vydání

EUROPEAN STROKE JOURNAL, LONDON, SAGE PUBLICATIONS LTD, 2019, 2396-9873

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30210 Clinical neurology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Kód RIV

RIV/00216224:14110/19:00121485

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1177/2396987319844690

UT WoS

000485316800007

Klíčová slova anglicky

Ischaemic stroke; randomised trial; treatment; hypothermia; cooling

Štítky

Excelence Science, FNUSA, RIV, rivok, Stroke, user

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 28. 4. 2021 09:48, Mgr. Tereza Miškechová

Anotace

V originále

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 degrees 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 degrees 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.

Návaznosti

90090, velká výzkumná infrastruktura

Název: CZECRIN II

Citovat

WORP VAN DER, H. B,, M. R. MACLEOD, P. M. W. BATH, R. BATHULA, H. CHRISTENSEN, B. COLAM, C. CORDONNIER, J. DEMOTES-MAINARD, I. DURAND-ZALESKI, C. GLUUD, J. C. JAKOBSEN, B. KALLMUNZERI, R. KOLLMAR, D. W. KRIEGER, K. R. LEES, D. MICHALSKI, C. MOLINA, J. MONTANER, R. O. ROINE, J. PETERSSON, R. PERRY, N. SPRIGG, D. STAYKOV, I. SZABO, G. VANHOOREN, J. M. WARDLAW, P. WINKEL, S. SCHWAB, S. SCHWAB, C. HOBOHM, H. SCHNEIDER, K. WARTENBERG, J. BERROUSCHOT, M. LORENZ, H. C. CHRISTENSEN, N. SPRIGG, R. BATHULA, P. FITZSIMMONS, R. PERRY, K. SAASTAMOINEN, B. C. CREAGH-BROWN, A. SWEENIE, R. LINDERT, M. RUBIERA, J. SERENAL, G. VANHOOREN, P. DESFONTAINES, C. CORDONNIER, I. SIBON, D. JATUZIS a F. ORZI. Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicentre, randomised, phase III clinical trial. EUROPEAN STROKE JOURNAL. LONDON: SAGE PUBLICATIONS LTD, 2019, roč. 4, č. 3, s. 254-262. ISSN 2396-9873. Dostupné z: https://dx.doi.org/10.1177/2396987319844690.

@article{1763958,
   author = {Worp van der, H. B, and Macleod, M. R. and Bath, P. M. W. and Bathula, R. and Christensen, H. and Colam, B. and Cordonnier, C. and DemotesandMainard, J. and DurandandZaleski, I. and Gluud, C. and Jakobsen, J. C. and Kallmunzeri, B. and Kollmar, R. and Krieger, D. W. and Lees, K. R. and Michalski, D. and Molina, C. and Montaner, J. and Roine, R. O. and Petersson, J. and Perry, R. and Sprigg, N. and Staykov, D. and Szabo, I. and Vanhooren, G. and Wardlaw, J. M. and Winkel, P. and Schwab, S. and Schwab, S. and Hobohm, C. and Schneider, H. and Wartenberg, K. and Berrouschot, J. and Lorenz, M. and Christensen, H. C. and Sprigg, N. and Bathula, R. and Fitzsimmons, P. and Perry, R. and Saastamoinen, K. and CreaghandBrown, B. C. and Sweenie, A. and Lindert, R. and Rubiera, M. and Serenal, J. and Vanhooren, G. and Desfontaines, P. and Cordonnier, C. and Sibon, I. and Jatuzis, D. and Orzi, F.},
   article_location = {LONDON},
   article_number = {3},
   doi = {http://dx.doi.org/10.1177/2396987319844690},
   keywords = {Ischaemic stroke; randomised trial; treatment; hypothermia; cooling},
   language = {eng},
   issn = {2396-9873},
   journal = {EUROPEAN STROKE JOURNAL},
   title = {Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicentre, randomised, phase III clinical trial},
   url = {https://journals.sagepub.com/doi/pdf/10.1177/2396987319844690},
   volume = {4},
   year = {2019}
}

TY  - JOUR
ID  - 1763958
AU  - Worp van der, H. B, - Macleod, M. R. - Bath, P. M. W. - Bathula, R. - Christensen, H. - Colam, B. - Cordonnier, C. - Demotes-Mainard, J. - Durand-Zaleski, I. - Gluud, C. - Jakobsen, J. C. - Kallmunzeri, B. - Kollmar, R. - Krieger, D. W. - Lees, K. R. - Michalski, D. - Molina, C. - Montaner, J. - Roine, R. O. - Petersson, J. - Perry, R. - Sprigg, N. - Staykov, D. - Szabo, I. - Vanhooren, G. - Wardlaw, J. M. - Winkel, P. - Schwab, S. - Schwab, S. - Hobohm, C. - Schneider, H. - Wartenberg, K. - Berrouschot, J. - Lorenz, M. - Christensen, H. C. - Sprigg, N. - Bathula, R. - Fitzsimmons, P. - Perry, R. - Saastamoinen, K. - Creagh-Brown, B. C. - Sweenie, A. - Lindert, R. - Rubiera, M. - Serenal, J. - Vanhooren, G. - Desfontaines, P. - Cordonnier, C. - Sibon, I. - Jatuzis, D. - Orzi, F.
PY  - 2019
TI  - Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicentre, randomised, phase III clinical trial
JF  - EUROPEAN STROKE JOURNAL
VL  - 4
IS  - 3
SP  - 254-262
EP  - 254-262
PB  - SAGE PUBLICATIONS LTD
SN  - 23969873
KW  - Ischaemic stroke
KW  - randomised trial
KW  - treatment
KW  - hypothermia
KW  - cooling
UR  - https://journals.sagepub.com/doi/pdf/10.1177/2396987319844690
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 degrees 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 degrees 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.
ER  -

WORP VAN DER, H. B,, M. R. MACLEOD, P. M. W. BATH, R. BATHULA, H. CHRISTENSEN, B. COLAM, C. CORDONNIER, J. DEMOTES-MAINARD, I. DURAND-ZALESKI, C. GLUUD, J. C. JAKOBSEN, B. KALLMUNZERI, R. KOLLMAR, D. W. KRIEGER, K. R. LEES, D. MICHALSKI, C. MOLINA, J. MONTANER, R. O. ROINE, J. PETERSSON, R. PERRY, N. SPRIGG, D. STAYKOV, I. SZABO, G. VANHOOREN, J. M. WARDLAW, P. WINKEL, S. SCHWAB, S. SCHWAB, C. HOBOHM, H. SCHNEIDER, K. WARTENBERG, J. BERROUSCHOT, M. LORENZ, H. C. CHRISTENSEN, N. SPRIGG, R. BATHULA, P. FITZSIMMONS, R. PERRY, K. SAASTAMOINEN, B. C. CREAGH-BROWN, A. SWEENIE, R. LINDERT, M. RUBIERA, J. SERENAL, G. VANHOOREN, P. DESFONTAINES, C. CORDONNIER, I. SIBON, D. JATUZIS a F. ORZI. Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicentre, randomised, phase III clinical trial. \textit{EUROPEAN STROKE JOURNAL}. LONDON: SAGE PUBLICATIONS LTD, 2019, roč.~4, č.~3, s.~254-262. ISSN~2396-9873. Dostupné z: https://dx.doi.org/10.1177/2396987319844690.

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