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Prehospital use of magnesium sulfate as neuroprotection in acute stroke.

ABSTRACT: Magnesium sulfate is neuroprotective in preclinical models of stroke and has shown signals of potential efficacy with an acceptable safety profile when delivered early after stroke onset in humans. Delayed initiation of neuroprotective agents has hindered earlier phase 3 trials of neuroprotective agents.We randomly assigned patients with suspected stroke to receive either intravenous magnesium sulfate or placebo, beginning within 2 hours after symptom onset. A loading dose was initiated by paramedics before the patient arrived at the hospital, and a 24-hour maintenance infusion was started on the patient's arrival at the hospital. The primary outcome was the degree of disability at 90 days, as measured by scores on the modified Rankin scale (range, 0 to 6, with higher scores indicating greater disability).Among the 1700 enrolled patients (857 in the magnesium group and 843 in the placebo group), the mean (±SD) age was 69±13 years, 42.6% were women, and the mean pretreatment score on the Los Angeles Motor Scale of stroke severity (range, 0 to 10, with higher scores indicating greater motor deficits) was 3.7±1.3. The final diagnosis of the qualifying event was cerebral ischemia in 73.3% of patients, intracranial hemorrhage in 22.8%, and a stroke-mimicking condition in 3.9%. The median interval between the time the patient was last known to be free of stroke symptoms and the start of the study-drug infusion was 45 minutes (interquartile range, 35 to 62), and 74.3% of patients received the study-drug infusion within the first hour after symptom onset. There was no significant shift in the distribution of 90-day disability outcomes on the global modified Rankin scale between patients in the magnesium group and those in the placebo group (P=0.28 by the Cochran-Mantel-Haenszel test); mean scores at 90 days did not differ between the magnesium group and the placebo group (2.7 in each group, P=1.00). No significant between-group differences were noted with respect to mortality (15.4% in the magnesium group and 15.5% in the placebo group, P=0.95) or all serious adverse events.Prehospital initiation of magnesium sulfate therapy was safe and allowed the start of therapy within 2 hours after the onset of stroke symptoms, but it did not improve disability outcomes at 90 days. (Funded by the National Institute of Neurological Disorders and Stroke; FAST-MAG ClinicalTrials.gov number, NCT00059332.).

SUBMITTER: Saver JL

PROVIDER: S-EPMC4920545 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Prehospital use of magnesium sulfate as neuroprotection in acute stroke.

Saver Jeffrey L JL Starkman Sidney S Eckstein Marc M Stratton Samuel J SJ Pratt Franklin D FD Hamilton Scott S Conwit Robin R Liebeskind David S DS Sung Gene G Kramer Ian I Moreau Gary G Goldweber Robert R Sanossian Nerses N

The New England journal of medicine 20150201 6

<h4>Background</h4>Magnesium sulfate is neuroprotective in preclinical models of stroke and has shown signals of potential efficacy with an acceptable safety profile when delivered early after stroke onset in humans. Delayed initiation of neuroprotective agents has hindered earlier phase 3 trials of neuroprotective agents.<h4>Methods</h4>We randomly assigned patients with suspected stroke to receive either intravenous magnesium sulfate or placebo, beginning within 2 hours after symptom onset. A ...[more]

PMID: 25651247

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Project description:Background and Purpose- We used a decision analysis approach to analyze triage strategies for patients with acute stroke symptoms while accounting for prehospital large vessel occlusion (LVO) screening methods and key time metrics. Methods- Our decision analysis compared anticipated functional outcomes for patients within the IV-tPA (intravenous tissue-type plasminogen activator) treatment window in the mothership and drip-and-ship frameworks. Key branches of the model included IV-tPA eligibility, presence of an LVO, and endovascular therapy eligibility. Our decision analysis evaluated 2 prehospital LVO screening approaches: (1) no formal screening and (2) the use of clinical LVO screening scales. An excellent outcome was defined as modified Rankin Scale scores 0-1. Probabilities and workflow times were guideline-based or imputed from published studies. In sensitivity analyses, we individually and jointly varied transport time to the nearest primary stroke center, additional time required to transport directly to a comprehensive stroke center, and LVO screening scale predictive probabilities. We evaluated 2 separate scenarios: one in which ideal time metrics were achieved and one under current real-world metrics. Results- In the ideal metrics scenario, the drip-and-ship strategy was almost always favored in the absence of formal LVO screening. For patients screened positive for an LVO, mothership was favored if the additional transport time to the comprehensive stroke center was <3 to 23 minutes. Under real-world conditions, in which primary stroke center workflow is slower than ideal, the mothership strategy was favored in more scenarios, regardless of formal LVO screening. For example, mothership was favored with an additional transport time to the comprehensive stroke center of <32 to 99 minutes for patients screened positive for an LVO and <28 to 39 minutes in the absence of screening. Conclusions- Joint consideration of LVO probability, screening, workflow times, and transport times may improve prehospital stroke triage. Drip-and-ship was more favorable when more ideal primary stroke center workflow times were modeled.

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Prehospital use of magnesium sulfate as neuroprotection in acute stroke.

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Prehospital use of magnesium sulfate as neuroprotection in acute stroke.

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