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N Engl J Med. 2015 Feb 5;372(6):528-36. doi: 10.1056/NEJMoa1408827.

Prehospital use of magnesium sulfate as neuroprotection in acute stroke.

Collaborators (1220)

Kramer I, Ali A, Andruss K, Beck B, Chin S, Conneen D, Copeland D, Crisan A, Gale L, Ganguly G, Gonzalez JE, Helfgott P, Hovanessian H, Jarema E, Liu M, Martin ML, Meyer G, Minassian H, Nguyen T, Rison R, Salinas M, Sato A, Shapiro R, Shook GD, Suleiman M, Thomas M, Zoraster R, Aguayo A, Balauag K, Coleman N, Feudi S, Henthorn S, Moreau G, Anderegg C, Barba C, Burden B, Bush G, Carrillo-Nunez I, Carruthers G, Chuang K, Collier J, Crawford B, Crowley J, DiMassa G, Fisher J, Forgey R, Gupta A, Hofmann G, Huang E, Kaji A, Kim D, Koenig W, Koplovsky A, Lampe CJ, Lee T, Massoudian B, Nguyen T, Omidvar O, Patel N, Raifiee S, Ramezan-Arab N, Rutkowski A, Sebastian R, Shey R, Stone A, Taraska R, Wittenberg A, Youngquist S, Zeumer C, Coleman N, Fitzgerald M, McCall K, Nighswonger B, Nye P, Real C, Sanoff R, Goldweber R, Crabb J, Fineman I, Gregory W, Kalter S, Kilaghbian T, Leung J, Levenson H, Lew B, Luna J, Mikhail AA, Minazad Y, Muller R, Nelsen M, Ohanian A, Papish MA, Rhee P, Rho JH, Salinas M, Sotiropoulos G, Ulick D, Vargas X, Willard D, Williams J, Yang R, Zielinski S, Gordon M, Feudi S, Lahn A, Hodgson K, Hoffman M, Starkman S, Ali L, Doojin K, Kim-Tenser M, Liebeskind D, Ovbiagele BI, Restrepo-Jimenez L, Sanossian N, Saver J, Selco S, Valdes-Sueiras M, Devereux G, Theaker S, Haley T, Shoji K, Amin D, Baldridge B, Carr FJ, Charfen M, Chavez R, Co S, Cohen MR, Conrad W, Duong B, Finkel M, Gausche-Hill M, Louie A, Mueller J, Rederich G, Ullman B, Vournas J, Zibulewsky J, Devereux G, Haley T, Hodgson K, Tarnay M, Anhalt E, Medina C, Miura B, Nakkim E, Pratt F, Presser D, Rederich G, Schugt J, Shen AH, Sulmeyer G, Tseng P, Ullman B, Wong C, Devereux G, McCall K, Haley T, Geiderman J, Torbati S, Altman K, Andiman R, Bibb J, Chow W, Cohen S, Corre K, Das A, Eliashiv D, Espy C, Fishkin J, Frankle D, Friedman L, Gardner S, Gorinshtein I, Hackett T, Hallert G, Hardy D, Jeffords B, Katz D, Kulkarni R, Lin W, Loftus J, Lyden P, Mandavia D, Mandavia S, Massey E, Merman J, Miller C, Moheet A, Palestrant D, Pulst S, Rovner D, Rudd S, Shaolian N, Silka P, Singh R, Song S, Stokol C, Sun B, Uzun G, Waters M, Whiteman P, Sanoff R, Schwarzman P, Akopov S, Belafsky M, Biren P, Campen A, Cruz E, Faisal F, Goldberg R, Hanna A, Herrera C, Jain R, Karayan R, Keane C, Kishineff SE, Lai R, Lee S, LeMay L, Lum F, Martin F, Marvi M, Obligato P, Oveian M, Purino L, Sarti M, Simic P, Toth J, Wang T, Wells LE, Sanoff R, Agron M, Apelian R, Bobo C, Burke J, Cabasso P, Fakoory J, Fauble TJ, Grant JD, Leung J, Levin J, Lisk J, Liu JC, Lynch RJ, Maatz RE, Mucia J, Ngo PX, Romero H, Westerband BP, Wogensen K, Craig S, Gordon M, Nye P, Ross L, Sanoff R, Flaherty H, Anis J, Cormier C, Deuson T, Dhillon S, Henry D, Hook R, Hyde D, Lawrence TB, Liker M, Melik-Abrahamian F, Meratee M, Patel H, Privett D, Sahagun O, Schmidt D, Schultz CM, Schultz M, Sutter G, Wallace R, Zappacosta R, Ziemba J, Devereux G, Tone B, Lynn J, Allison R, Auerbach F, Benoit R, Boyatt P, Brown M, DeTrana F, Deuson T, Gertz M, Gregory W, Gupta M, Hemingway TJ, Janumpally L, Lee T, Leidner M, Menchine M, Nakagawa J, Shanmugam V, Snyder E, Spencer C, Stock L, Watson J, Binning A, Gordon M, Feudi S, Henthorn S, Ingram A, Tone B, Johnston B, Bautista M, Blair B, Dimassa G, Hernandez A, Ho HH, Iskander R, Jacobs S, Kaminsky R, Liu A, Murray J, Pham M, Phillips M, Plosay J, Stanley J, Swanson P, Takano S, Tinger E, Webb M, Hoffman M, Theaker S, Tone B, Jones S, Abrahams J, Brandes D, Cohenour R, Cole S, Gantwerker B, Hyde D, Jeon E, Kijner D, McConnellogue J, McKittrick A, Meindlholman J, Mi W, Rokos I, Sachs J, Savur V, Weinberg L, Ziman R, Feudi S, Padilla V, Pierce B, Moore K, Boettger M, Burke G, Desai BH, Dorosh R, Edholm T, Friedman H, Jamehdor A, Janssen M, Kim JS, Lee J, Maas L, Murphy G, Nakamoto K, Pableo G, Piccinini P, Rhee B, Ries J, Salazar SM, Schatz I, Schultz M, Shook V, Squire B, Ujkic P, Aguayo A, Devereux G, Gordon M, Grace A, Fisher J, Blum M, Brown J, Cummings B, Deng C, Diaz J, El-Tobgy E, Hogen V, Inglizian G, Kijner G, Lalli J, Liker M, Mendes M, Nayyar K, Pousson G, Sarti M, Sung J, Wang S, Waskiewicz T, Zlidenny A, Sanoff R, Tone B, Kroes J, Jetton B, Kassinove AS, Serna M, Svimonoff C, Vafadari P, Craig S, Fitzgerald M, Hodgson K, Onwunyi C, Real C, Tone B, Davis M, Cervantes JL, Copeland D, Derbigny M, Flashman R, Harper R, Higgins SD, Kaplan A, Koplovsky A, Louden M, Mansour K, Miller VH, Pelayo A, Stephen M, Wong P, McCall K, Real C, Tatgenhorst D, Lee C, Adl-Tabatabai N, Ayvazyan S, Burke J, Cardillo AM, Chiu PY, Fineman I, Finestead B, Friend D, Gibbs H, Kotikian S, Lee L, Lieberman R, Noll E, Shin P, Stanford B, Thompson D, Utas P, Voskanian S, Wong A, Wong E, Yegyan G, Lahn A, McCall K, Sanoff R, Tone B, Weiss L, Allen J, Bastian E, Caira L, De La Torre J, El-Tobgy E, Engelberg T, Gerberich B, Gharakhani H, Jeon E, Jones M, Kirk M, Kuban A, Martinez M, Platzer M, Savur V, Sengupta V, Sindell G, Butel J, Ingram A, Padilla V, Sanoff R, Ghurabi W, Bei R, Charfen M, Chenevert M, Cokely H, Futernick M, Halem L, Kim D, Lutsky Z, McCain S, Plosay J, Pulera M, Starkman S, Haley T, Theaker S, Futernick M, Ahn BS, Alfred G, Banerji S, Cashatt T, Duong B, Graham R, Gwaltney S, Haas GR, Keswani V, Lee TS, Levy S, Liu A, Liu S, Lorber P, McDavit C, Mewaldt K, Mitchell E, Myers D, Myher C, Ogle M, Partnow J, Raetnow J, Rose E, Sims J, Splawn R, Thai TH, Victor B, Wagner D, Waltz K, Warner C, Zadini G, Zide E, Butel J, Hoffman M, Padilla V, Sanoff R, Smith D, Chang D, Greenspan J, Marshall L, Novom S, Cavanaugh J, Sanoff R, Kino R, Amos E, Bash I, Candioty V, Cardillo A, Chen G, Cokely H, Cotner E, Diaz S, Enomoto H, Froehler MT, Gertz M, Giombetti R, Gold M, Gross H, Grossman D, Jordan S, Kaminsky R, Keane C, Kudrow D, McClure-Poffenberger CA, Mobin F, O'Connor E, O'Connor R, Orfuss C, Partnow J, Pfahler J, Pulera M, Seth S, Shimizu R, Shum N, Starkman S, Tizes-Gold S, Treciokas L, Urstein S, Uzun G, Varzgah A, Weitz M, Woo A, Yarema V, Zibulewsky J, Gordon M, Grace A, Hodgson K, Shea SR, Brown W, Cichon PD, Deutsch MB, Diaz MA, Fong B, Grant V, Haghighat SS, Heller B, Joyner M, Lizaso KV, McCall JS, McFarland DW, Mehta P, Melendez R, Mistry S, Molaie M, Munoz D, Reddy UR, Shaw M, Stamler KD, Vernon A, Fitzgerald M, Hodgson K, McCall K, Theaker S, Holland JP, Hatherley JA, Jones JL, Kojian J, Owashi N, Pak KM, Aguayo A, Balauag K, Coleman N, Feudi S, Hoffman M, Slay R, Conovaloff L, Giombetti R, Gonella P, Kay R, Kheradyar D, Kolodny M, Sheer W, Shoji K, Haley T, Hodgson K, Sanoff R, Tatgenhorst D, Tone B, Eckstein M, Calder K, Giannotta S, Herbert M, Johnson C, Mandavia D, Sanossian N, Sung G, Hodgson K, Pierce B, Bennett V, Janumpally L, Shanmugam V, Devereux G, Gordon M, Binning A, Ingram A, Tone B, Tashman D, Berkenbile L, Chen J, Crabb J, Dorian A, Finstead B, Hackett T, Lee L, Montoya M, Nikbakht F, Thompson D, Wilson E, Gordon M, Henthorn S, Lahn A, Pierce B, Theaker S, Tone B, Brewster GS, Andersson PB, Baca R, Bell M, Canby N, Carlisle E, Cohenour R, Dennis F, Diaz J, Edwards I, Goldfarb S, Green V, Greenspan J, Hirsch O, Jeon E, Lawrence T, Lopez-Cuenca VM, Mi W, Moy K, Platzer M, Reyes C, Sabahi H, Sauer T, Sung J, Sutter G, Weinberg L, Ziman R, Butel J, Devereux G, Henthorn S, Ingram A, Phoenix R, Sanoff R, Swendson H, Agron M, Aragona J, Dannenberg B, Friedlander J, Khan F, Lee L, Masri-Phillips SS, Ngo P, Noll E, Rapetti E, Westerband B, Butel J, Feudi S, Lahn A, Sanoff R, Tone B, Ricketts VB, Au J, Dyne P, Hemingway TJ, Jang T, Kamangar N, Kulkarni R, Lundberg S, Melik-Abrahamian F, Moran G, Ong S, Ovbiagele B, Pi J, Richman M, Rokos I, Rosenbloom R, Shlamovitz G, Talan DA, Valdes-Sueiras M, Weitz M, Yick D, Hodgson K, Pierce B, Balkian G, Balogh M, Chen H, Danesh M, Farfan F, Gabrielian A, Jong D, LaFemenia M, Yu S, Cavanaugh J, Feudi S, Nye P, Padilla V, Swendson H, Pagano J, Astidillo DT, Carrillo AE, Chon J, Giem P, Johnson J Jr, Judson J, Konia N, Mohsen AI, Peek CG, Tsai D, Feudi S, Valenti K, Sous N, Ajani Z, Domiano ML, Enos BE, Gowrinathan RN, Hopkins MC, Hwang JY, Jadvar RN, Krainin JG, Lin K, Mull BR, Potrebic S, Salem L, Sanders LM, Schmitz CF, Schoeman GD, Smith MP, Subramanian SR, Thompson BE, Tilles IH, Ungar RA, Yoo PH, Cavanaugh J, Devereux G, Ingram A, McCall K, Shea SR, Brown RW, Carrillo-Nunez I, Cichon PD, Deutsch MB, Diaz M, Fong B, Grant V, Haghighat SS, Heller B, Joyner M, Lawrence J, Lee T, Lizaso K, McCall J, McFarland DW, Mistry S, Munoz D, Reddy UR, Shaw M, Stamler KD, Vernon A, Williams J, Fitzgerald M, McCall K, Nighswonger B, Real C, Tone B, Carney S, Chavoshi Z, Dennis F, Eisner D, Gross H, Johnson KS, Lalli J, Lopata S, Ouligian G, Rosenbloom R, Singh R, Stagg S, Tomasi A, Vargas M, Feudi S, Hoffman M, Ingram A, Tatgenhorst D, Theaker S, Kiss D, Bullias BA, Chon J, Kojian J, Pak K, Sutikno-Ong R, Balauag K, Coleman N, Feudi S, Gausche-Hill M, Anderson TL, Burbulys D, Charfen M, Coates WC, Edwards-Lee T, Fernandez-Frackelton M, Goldberg M, Hockberger R, Kaji A, Lewis RJ, Lipsky A, McIntyre H, Niemann J, Peterson M, Pisupati D, Schmitz CF, Stevens C, Balauag K, Grace A, Hodgson K, Onwunyi C, Venturo AC, Tsai J, Alfred G, Anis J, Bush W, Carney S, Chavoshi Z, Hernandez A, Hernandez MF, Mandavia D, Mandavia S, Singh R, Sutter G, Vargas MT, Feudi S, Hoffman M, Ingram A, McCall K, Padilla V, Tatgenhorst D, Theaker S, Johnson R, Donnelly S, Prakash A, Slabaugh P, Binning A, Devereux G, Onwunyi C, Tone B, Venturo AC, Bush R, Azen S, Batmanis P, Derderian H, Fagan P, Hernandez MF, Jacob JA, Kwon D, Leistiko L, Novom S, Okpara O, Pham M, Prince J, Samaniego L, Zohrabian D, Cavanaugh J, Feudi S, Ingram A, Pierce B, Phoenix R, Swendson H, Theaker S, Lai M, De Cruz D, Goldberg SM, Hsu AC, Leung J, Lin JT, Sanagustin WC, Wade JF, Wang J, Williams JD, Xie SX, Craig S, Devereux G, Ingram A, Ross L, Weiss L, Bennett V, Biren P, Cashatt T, Hernandez M, Milstein D, Newman S, Ng C, Samaniego L, Tabib S, Testa N, Webb B, Van Zyl C, Ingram A, Henthorn S, Hoffman M, Hudgson K, Padilla V, Valenti K, Greenspan J, Anderson PB, Azen S, Carlisle E, Carrillo M, Cochrane D, Cohenour R, Dennis F, Edwards I, Goldfarb S, Jeon E, Lopez-Cuenca VM, Mi W, Paras Rde G, Pham M, Platzer M, Sabahi H, Sauer T, Siegel J, Weinberg L, Ziman R, Hodgson K, Nye P, Padilla V, Tone B, Fagan P, Banerji S, Harris B, Hatherley JA, Johnson D, Kerns R, Kuhn N, Lorber P, Oblitas D, Samaniego L, Volk D, Xie S, Binning A, Henthorn S, Nye P, Padilla V, Theaker S, Valenti K, Berry M, Binning A, Feudi S, MsCall K, Padilla V, Valenti K, Slay R, Conovaloff L, Gonella P, Kay R, Kheradyar D, Kolodny M, Sheer W, Shoji K, Yarnell B, Tatgenhorst D, Greenspan J, Andersson PB, Baca R, Bell M, Brewster GS, Canby N, Carlisle E, Cohenour R, De La Torre J, Dennis F, Diaz J, Edwards I, Goldfarb S, Green V, Hirsch O, Jeon E, Kwon D, Lawrence T, Lopez-Cuenca VM, Mi W, Moy K, Platzer M, Prince JA, Reyes C, Sabahi H, Sauer T, Sung J, Sutter G, Weinberg L, Wu T, Ziman R, Butel J, Ingram A, Hodgson K, Phoenix R, Swendson H, Tone B, Stratton S, Eckstein M, Pratt F, Ali L, Kidwell C, Kim D, Liebeskind D, Ovbiagale B, Restrepo L, Sanossian N, Saver J, Starkman S, Nighswonger B, Sanoff R, Koenig W, Greco T, Bath K, Ciabarra A, Lam A, Larsen C, Moon J, Song E, Waldman S, Cross L, Devereux G, Nasseri N, Cloud W, Brown D, Hunt M, Ly A, Muir J, Nakashioya H, Puangco J, Cross L, Perez A, Jetton B, Kroes J, Patel N, Ramezan-Arab N, Cross L, Feudi S, Nasseri N, Anderson PG, Carrillo-Nunez I, Maistros P, Miller C, Miranda A, Vespa P, Cross L, Perez A, Kozak R, Allgower L, Cummings M, Firestone D, Gee J, Kaplan M, Kwon K, Lawson A, Patel R, Cross L, Pierog J, Abdelhadi A, Chang R, Ghiassi A, Hayat S, Hsu K, Mina-Araghi R, Preston J, Roum J, Sjauwfoekloy D, Smethurst P, Hodgson K, Nasseri N, Perez A, Brash S, Kim J, Chen J, Escober WT, Grewal G, Holstein D, Huynh V, Imam I, Khuu N, Lew C, Lombardi D, Zeltser L, Cross L, Taub M, Burbridge L, Chen D, Haas R, Kingston R, Le D, Medina C, Newton J, Schultz M, Shen M, Siedenburg E, Traynor E, Cross L, Langdorf M, Burns M, Chakravarthy B, Cramer S, Fox JC, Gomez M, Jain V, Lotfipour S, Oman J, Rudkin S, Wong AC, Cross L, Perez A, Stratton S, Ali L, Kidwell C, Kim D, Liebeskind D, Ovbiagale B, Restrepo L, Sanossian N, Saver J, Starkman S, Cross L, McCall K, Perez A, Sadighi A, Filip B, Dorsey D, Craig S, Paras M, Boyle N, Craig S, Lahn A, Klutch R, Krause J, Cerda S, Leeper D, Chatfield F, Grace A, Gaughran G, Hamilton S, Das A, Greene K, Haley E Jr, Sherman D, Benavente O, Dawson J, Jauch E, Llinas R, Levine SR, Villablanca P, Liebeskind DS, Janis S, Moy C, Albers G, Alldredge B, Barsan W, Clarke W, Grotta J, Lees K, Longstreth W, Muir K, Sacco R.

Abstract

BACKGROUND:

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.

METHODS:

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).

RESULTS:

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.

CONCLUSIONS:

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.).

PMID:
25651247
PMCID:
PMC4920545
DOI:
10.1056/NEJMoa1408827
[Indexed for MEDLINE]
Free PMC Article
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