COOLIST (Cooling for Ischemic Stroke Trial)
A Multicenter, Open, Randomized, Phase II, Clinical Trial
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Abstract
Background and Purpose—Animal
studies suggest that cooling improves outcome after ischemic stroke. We
assessed the feasibility and safety of surface cooling to different
target temperatures in awake patients with acute ischemic stroke.
Methods—A
multicenter, randomized, open, phase II, clinical trial, comparing
standard treatment with surface cooling to 34.0°C, 34.5°C, or 35.0°C in
awake patients with acute ischemic stroke and an National Institutes of
Health Stroke Scale score of ≥6, initiated within 4.5 hours after
symptom onset and maintained for 24 hours. The primary outcome was
feasibility, defined as the proportion of patients who had successfully
completed the assigned treatment. Safety was a secondary outcome.
Results—Inclusion
was terminated after 22 patients because of slow recruitment. Five
patients were randomized to 34.0°C, 6 to 34.5°C, 5 to 35.0°C (cooling
was initiated in 4), and 6 to standard care. No (0%), 1 (17%), and 3
(75%) patients, respectively, completed the assigned treatment (P=0.03). No (0%), 2 (33%), and 4 (100%) patients reached the target temperature (P=0.01).
Pneumonia occurred in 8 cooled patients but not in controls (absolute
risk increase, 53%; 95% confidence interval, 28–79%; P=0.002).
Conclusions—In
awake patients with acute ischemic stroke, surface cooling is feasible
to 35.0°C, but not to 34.5°C and 34.0°C. Cooling is associated with an
increased risk of pneumonia. (Did it work or not?) I don't care if you were just testing feasibility, tell us the real results.
Clinical Trial Registration—URL: http://www.trialregister.nl. Unique identifier: NTR2616.
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