Abstract | BACKGROUND AND PURPOSE: METHODS: Safety procedures and 4°C saline infusions for faster cooling were added to the ICTuS trial (Intravascular Cooling in the Treatment of Stroke) protocol. A femoral venous intravascular cooling catheter after intravenous recombinant tissue-type plasminogen activator in eligible patients provided 24 hours cooling followed by a 12-hour rewarm. Serial safety assessments and imaging were performed. The primary end point was 3-month modified Rankin score 0,1. RESULTS: Of the intended 1600 subjects, 120 were enrolled before the study was stopped. Randomly, 63 were to receive hypothermia plus antishivering treatment and 57 normothermia. Compared with previous studies, cooling rates were improved with a cold saline bolus, without fluid overload. The intention-to-treat primary outcome of 90-day modified Rankin Score 0,1 occurred in 33% hypothermia and 38% normothermia subjects, odds ratio (95% confidence interval) of 0.81 (0.36-1.85). Serious adverse events occurred equally. Mortality was 15.9% hypothermia and 8.8% normothermia subjects, odds ratio (95% confidence interval) of 1.95 (0.56-7.79). Pneumonia occurred in 19% hypothermia versus 10.5% in normothermia subjects, odds ratio (95% confidence interval) of 1.99 (0.63-6.98). CONCLUSIONS: CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01123161.
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Authors | Patrick Lyden, Thomas Hemmen, James Grotta, Karen Rapp, Karin Ernstrom, Teresa Rzesiewicz, Stephanie Parker, Mauricio Concha, Syed Hussain, Sachin Agarwal, Brett Meyer, Julie Jurf, Irfan Altafullah, Rema Raman, Collaborators |
Journal | Stroke
(Stroke)
Vol. 47
Issue 12
Pg. 2888-2895
(12 2016)
ISSN: 1524-4628 [Electronic] United States |
PMID | 27834742
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | © 2016 American Heart Association, Inc. |
Topics |
- Aged
- Aged, 80 and over
- Female
- Follow-Up Studies
- Humans
- Hypothermia, Induced
(adverse effects, instrumentation, methods, standards)
- Male
- Middle Aged
- Outcome Assessment, Health Care
- Single-Blind Method
- Stroke
(therapy)
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