van der Worp, HB; Macleod, MR; Bath, PMW; Bathula, R; Christensen, H; Colam, B; Cordonnier, C; ... Schwab, S; + view all van der Worp, HB; Macleod, MR; Bath, PMW; Bathula, R; Christensen, H; Colam, B; Cordonnier, C; Demotes-Mainard, J; Durand-Zaleski, I; Gluud, C; Jakobsen, JC; Kallmünzer, B; Kollmar, R; Krieger, DW; Lees, KR; Michalski, D; Molina, C; Montaner, J; Roine, RO; Petersson, J; Perry, R; Sprigg, N; Staykov, D; Szabo, I; Vanhooren, G; Wardlaw, JM; Winkel, P; Schwab, S; - view fewer (2019) Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicentre, randomised, phase III clinical trial. European Stroke Journal , 4 (3) pp. 254-262. 10.1177/2396987319844690.

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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.

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