All my previous research posts on this suggested no useful intervention. Obviously no protocols were ever written on hypothermia so everyone is still shooting in the dark. The result being that survivors are still screwed with no consequences to the doctors who haven't written up protocols on this. Don't you just love incompetence?
- hypothermia (43)
ESJ Comment: Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicenter, randomized, phase III clinical trial
Comment by Nicolas Martinez-Majander, Department of Neurology, Helsinki University Hospital, Finland
Original Article: H
Bart van der Worp, Malcolm R Macleod, Philip MW Bath et al, 2019.
Therapeutic hypothermia for acute ischaemic stroke. Results of a
European multicenter, randomized, phase III clinical trial
https://journals.sagepub.com/doi/10.1177/2396987319844690
Previous systematic reviews and
meta-analyses of animal studies have shown that therapeutic hypothermia
is highly effective in reducing infarct size and improving neurological
outcome. Hypothermia can affect several ongoing processes in the
penumbra, such as counteracting edema, reducing lactacidosis, and
inhibiting free radical formation and apoptosis. However, there is only
little evidence of therapeutic hypothermia in human stroke.
In this paper of ESJ, van der Worp and
colleagues reported results of EuroHYP-1, a European multicentre,
randomized, phase III clinical trial which aimed to assess whether
modest systemic cooling started within 6 hours of symptom onset could
improve functional outcome at three months in awake patients with acute
ischaemic stroke. These patients were allocated to hypothermia (target
body temperature of 34-35°C either with intravenous infusion or a
pre-specified surface cooling method) within 6 h after onset of stroke.
Hypothermia was maintained for 12 to 24 hours. The primary outcome was
mRS score at 91 days, assessed by independent blinded adjudicators.
Although the target sample size was 1500 patients, the trial was stopped
after inclusion of 98 patients, at 23 study sites, because of slow
recruitment. Of these, 49 were randomized to hypothermia and 49 to
control arm. The intention-to-treat analysis showed no difference
between the groups (OR for good outcome, 1.01; 95% CI, 0.48-2.13; p=0.97).
38% in the hypothermia group and 29% controls had at least one serious
adverse event, such as pneumonia and symptomatic intracranial
haemorrhage. Unfortunately however, the final sample was underpowered to
detect any benefit or harm of therapeutic hypothermia. Furthermore, in
about two thirds of patients randomized to hypothermia, it was not
possible to achieve cooling target of body temperature of 34-35 °C,
mainly because of shivering and discomfort. As the authors conclude,
despite of a well-balanced and robust study protocol, the feasibility of
cooling needs to be improved before launching any new trials.
Reference
H Bart van der Worp, Malcolm R Macleod,
Philip MW Bath et al, 2019. Therapeutic hypothermia for acute ischaemic
stroke. Results of a European multicenter, randomized, phase III
clinical trial. European Stroke Journal. DOI: 10.1177/2396987319844690 https://journals.sagepub.com/doi/10.1177/2396987319844690
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