Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial
NCT ID: NCT00059332
Last Updated: 2015-08-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1700 participants
INTERVENTIONAL
2005-01-31
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intravenous Magnesium Sulphate in Acute Ischemic Stroke
NCT04412850
Intra-Arterial Magnesium Therapy After Mechanical Thrombectomy in Acute Ischemic Stroke
NCT06956521
Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke
NCT00933868
Proof of Concept (POC) in Patients With Ischaemic Stroke
NCT01808261
Magnesium And Verapamil After Recanalization in Ischemia of the Cerebrum: a Clinical and Translational Study.
NCT02912663
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Currently, tissue plasminogen activator (rt-PA) is the only approved treatment for acute ischemic stroke; however, its usefulness is limited because most patients cannot reach medical attention within the necessary 3-hour time window. In addition, rt-PA cannot be given in the field because it is contraindicated for treatment of patients with brain hemorrhage.
The purpose of this multi-center, randomized, double-blind trial is to demonstrate that paramedic initiation of the neuroprotective agent magnesium sulfate in the field is an effective and safe treatment for acute stroke. This study will analyze magnesium sulfate, an experimental therapy for stroke, versus placebo among ambulance-transported patients with acute stroke. This trial will also demonstrate that paramedics can safely, effectively, and rapidly start neuroprotective therapies for stroke.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Magnesium Sulfate
Magnesium sulfate (Mg) was administered intravenously with a 15 minute bolus load followed by a 24 hour infusion. The bolus-loading dose consisted of 4 grams Mg in 54 ml normal saline. The maintenance infusion contained 16 grams Mg diluted in 240 ml 0.9% normal saline, infused at 10 ml/hr for 24 hours. Paramedics in the field initiated the bolus-loading dose, administered at 216 ml/hr over 15 minutes through a rate controlled IV infusion set. The maintenance infusion was initiated in hospital immediately upon completion of the loading dose.
Magnesium Sulfate
Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
Normal saline
Normal saline was administered intravenously with a 15 minute bolus load followed by a 24 hour infusion. Paramedics in the field initiated the bolus-loading dose of 54 ml normal saline, administered at 216 ml/hr over 15 minutes through a rate controlled IV infusion set. The maintenance infusion was initiated in hospital immediately upon completion of the loading dose at 10 ml/hr for 24 hours.
Normal Saline
Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Magnesium Sulfate
Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
Normal Saline
Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 40-95, inclusive
* Last known well time within 2 hours of treatment initiation
* Deficit present for \>/= 15 minutes
Exclusion Criteria
* Rapidly improving neurologic deficit
* Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
* Systolic Blood Pressure (SBP) \< 90 or \> 220
* Known severe renal dysfunction (on dialysis or known chronic creatinine \> 3.0)
* Severe respiratory distress (O2 sat \< 90% or respiratory rate \< 12 or \>/= 24)
* Known second or third degree heart block with no pacemaker in place
* Major head trauma in the last 24 hours
* Recent stroke within prior 30 days
* Patient unable to give informed consent and no available on scene consent or assent provider
40 Years
95 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Jeffrey L. Saver
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jeffrey L. Saver
Professor of Neurology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeffrey Saver, M.D.
Role: PRINCIPAL_INVESTIGATOR
UCLA School of Medicine, Study Overall Principal Investigator
Sidney Starkman, M.D.
Role: PRINCIPAL_INVESTIGATOR
UCLA Stroke Center, Co-Principal Investigator
Marc Eckstein, M.D.
Role: PRINCIPAL_INVESTIGATOR
Los Angeles City Emergency Medical Service, Co-Principal Investigator
Samuel Stratton, MD
Role: PRINCIPAL_INVESTIGATOR
Los Angeles and Orange County Emergency Medical Services Agencies, Co-Principal Investigator
Frank Pratt, MD
Role: PRINCIPAL_INVESTIGATOR
Los Angeles County Emergency Medical Service, Co-Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Clinical Coordinating Center is: UCLA School of Medicine, 710 Westwood Plaza
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kazaryan SA, Shkirkova K, Saver JL, Liebeskind DS, Starkman S, Bulic S, Poblete R, Kim-Tenser M, Guo S, Conwit R, Villablanca P, Hamilton S, Sanossian N. The National Institutes of Health Stroke Scale is comparable to the ICH score in predicting outcomes in spontaneous acute intracerebral hemorrhage. Front Neurol. 2024 Jul 1;15:1401793. doi: 10.3389/fneur.2024.1401793. eCollection 2024.
Liotta EM, Maas MB, Prabhakaran S, Shkirkova K, Sanossian N, Liebeskind DS, Sharma L, Stratton S, Conwit R, Saver JL; FAST-MAG Investigators and Coordinators. Magnesium and Hematoma Expansion in Intracerebral Hemorrhage: A FAST-MAG Randomized Trial Analysis. Stroke. 2024 Feb;55(2):463-466. doi: 10.1161/STROKEAHA.123.043555. Epub 2023 Dec 21.
Balucani C, Levine SR, Sanossian N, Starkman S, Liebeskind D, Gornbein JA, Shkirkova K, Stratton S, Eckstein M, Hamilton S, Conwit R, Sharma LK, Saver JL. Neurologic Improvement in Acute Cerebral Ischemia: Frequency, Magnitude, Predictors, and Clinical Outcomes. Neurology. 2023 Mar 7;100(10):e1038-e1047. doi: 10.1212/WNL.0000000000201656. Epub 2022 Dec 7.
Fan S, Jang M, Kim-Tenser M, Shkirkova K, Liebeskind DS, Starkman S, Villablanca JP, Hamilton S, Naidech A, Saver JL, Sanossian N; FAST-MAG Investigators and Coordinators. Effect of Magnesium on Deterioration and Symptomatic Hemorrhagic Transformation in Cerebral Ischemia: An Ancillary Analysis of the FAST-MAG Trial. Cerebrovasc Dis. 2023;52(5):539-542. doi: 10.1159/000528385. Epub 2023 Jan 4.
Naidech AM, Shkirkova K, Villablanca JP, Sanossian N, Liebeskind DS, Sharma L, Eckstein M, Stratton S, Conwit R, Hamilton S, Saver JL; FAST-MAG Investigators and Coordinators. Magnesium Sulfate and Hematoma Expansion: An Ancillary Analysis of the FAST-MAG Randomized Trial. Stroke. 2022 May;53(5):1516-1519. doi: 10.1161/STROKEAHA.121.037999. Epub 2022 Apr 5.
Shkirkova K, Wang TT, Vartanyan L, Liebeskind DS, Eckstein M, Starkman S, Stratton S, Pratt FD, Hamilton S, Kim-Tenser M, Conwit R, Saver JL, Sanossian N. Quality of Acute Stroke Care at Primary Stroke Centers Before and After Certification in Comparison to Never-Certified Hospitals. Front Neurol. 2020 Jan 22;10:1396. doi: 10.3389/fneur.2019.01396. eCollection 2019.
Shkirkova K, Schuberg S, Balouzian E, Starkman S, Eckstein M, Stratton S, Pratt FD, Hamilton S, Sharma L, Liebeskind DS, Conwit R, Saver JL, Sanossian N; FAST-MAG Investigators and Coordinators. Paramedic Global Impression of Change During Prehospital Evaluation and Transport for Acute Stroke. Stroke. 2020 Mar;51(3):784-791. doi: 10.1161/STROKEAHA.119.026392. Epub 2020 Jan 20.
Shkirkova K, Saver JL, Starkman S, Wong G, Weng J, Hamilton S, Liebeskind DS, Eckstein M, Stratton S, Pratt F, Conwit R, Sanossian N; FAST-MAG Trial Coordinators and Investigators. Frequency, Predictors, and Outcomes of Prehospital and Early Postarrival Neurological Deterioration in Acute Stroke: Exploratory Analysis of the FAST-MAG Randomized Clinical Trial. JAMA Neurol. 2018 Nov 1;75(11):1364-1374. doi: 10.1001/jamaneurol.2018.1893.
Chung PW, Kim JT, Sanossian N, Starkmann S, Hamilton S, Gornbein J, Conwit R, Eckstein M, Pratt F, Stratton S, Liebeskind DS, Saver JL; FAST-MAG Investigators and Coordinators. Association Between Hyperacute Stage Blood Pressure Variability and Outcome in Patients With Spontaneous Intracerebral Hemorrhage. Stroke. 2018 Feb;49(2):348-354. doi: 10.1161/STROKEAHA.117.017701. Epub 2018 Jan 4.
Sanossian N, Rosenberg L, Liebeskind DS, Starkman S, Eckstein M, Stratton S, Pratt FD, Hamilton S, Kim-Tenser M, Sharma LK, Restrepo L, Valdes-Suieras M, Conwit R, Saver JL; FAST-MAG Investigators and Coordinators. A Dedicated Spanish Language Line Increases Enrollment of Hispanics Into Prehospital Clinical Research. Stroke. 2017 May;48(5):1389-1391. doi: 10.1161/STROKEAHA.117.014745. Epub 2017 Apr 7.
Sanossian N, Apibunyopas KC, Liebeskind DS, Starkman S, Burgos AM, Conwit R, Eckstein M, Pratt F, Stratton S, Hamilton S, Saver JL; FAST-MAG (Field Administration of Stroke Therapy-Magnesium) Investigators and Coordinators. Characteristics and Outcomes of Very Elderly Enrolled in a Prehospital Stroke Research Study. Stroke. 2016 Nov;47(11):2737-2741. doi: 10.1161/STROKEAHA.116.013318. Epub 2016 Sep 27.
Kim DH, Saver JL, Starkman S, Liebeskind DS, Ali LK, Restrepo L, Kim-Tenser M, Valdes-Sueiras M, Eckstein M, Pratt F, Stratton S, Hamilton S, Conwit R, Sanossian N; Field Administration of Stroke Therapy-Magnesium (FAST-MAG) Trial Nurse-Coordinators and Investigators. Enrollment Yield and Reasons for Screen Failure in a Large Prehospital Stroke Trial. Stroke. 2016 Jan;47(1):232-5. doi: 10.1161/STROKEAHA.115.011687. Epub 2015 Dec 10.
Sanossian N, Liebeskind DS, Eckstein M, Starkman S, Stratton S, Pratt FD, Koenig W, Hamilton S, Kim-Tenser M, Conwit R, Saver JL; FAST-MAG Investigators and Coordinators. Routing Ambulances to Designated Centers Increases Access to Stroke Center Care and Enrollment in Prehospital Research. Stroke. 2015 Oct;46(10):2886-90. doi: 10.1161/STROKEAHA.115.010264. Epub 2015 Aug 11.
Saver JL, Starkman S, Eckstein M, Stratton SJ, Pratt FD, Hamilton S, Conwit R, Liebeskind DS, Sung G, Kramer I, Moreau G, Goldweber R, Sanossian N; FAST-MAG Investigators and Coordinators. Prehospital use of magnesium sulfate as neuroprotection in acute stroke. N Engl J Med. 2015 Feb 5;372(6):528-36. doi: 10.1056/NEJMoa1408827.
Related Links
Access external resources that provide additional context or updates about the study.
The official FAST-MAG Clinical Trial website
Other Identifiers
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.