Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicentre, randomised, phase III clinical trial.
Ischaemic stroke
cooling
hypothermia
randomised trial
treatment
Journal
European stroke journal
ISSN: 2396-9881
Titre abrégé: Eur Stroke J
Pays: England
ID NLM: 101688446
Informations de publication
Date de publication:
Sep 2019
Sep 2019
Historique:
received:
30
11
2018
accepted:
27
02
2019
entrez:
28
1
2020
pubmed:
28
1
2020
medline:
28
1
2020
Statut:
ppublish
Résumé
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. 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. 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; 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. Before new trials are launched, the feasibility of cooling needs to be improved.
Identifiants
pubmed: 31984233
doi: 10.1177/2396987319844690
pii: 10.1177_2396987319844690
pmc: PMC6960691
doi:
Types de publication
Journal Article
Langues
eng
Pagination
254-262Subventions
Organisme : Medical Research Council
ID : G0300623
Pays : United Kingdom
Organisme : Medical Research Council
ID : G0400069
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_G1002455
Pays : United Kingdom
Informations de copyright
© European Stroke Organisation 2019.
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