Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review


  1. Fourth European stroke science workshop

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. European Stroke Organisation guidelines for the management of post-stroke seizures and epilepsy

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Treatment of intracerebral haemorrhage with tranexamic acid – A review of current evidence and ongoing trials

    Publikation: Bidrag til tidsskriftReviewForskningpeer review

  4. Cognitive Assessment at Bedside for iPAD: A preliminary Validation of a Novel Cognitive test for Stroke Patients

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  • EuroHYP-1 investigators
Vis graf over relationer

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.

TidsskriftEuropean Stroke Journal
Udgave nummer3
Sider (fra-til)254-262
Antal sider9
StatusUdgivet - sep. 2019

Bibliografisk note

© European Stroke Organisation 2019.

ID: 59134380