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1. Safety of intravenous alteplase within 4.5 hours for patients awakening with stroke symptoms.

Author

Victor C Urrutia, Roland Faigle, Steven R Zeiler, Elisabeth B Marsh, Mona Bahouth, Mario Cerdan Trevino, Jennifer Dearborn, Richard Leigh, Susan Rice, Karen Lane, Mustapha Saheed, Peter Hill, and Rafael H Llinas

Subjects
Medicine, Science
Abstract

BACKGROUND:Up to 25% of acute stroke patients first note symptoms upon awakening. We hypothesized that patients awaking with stroke symptoms may be safely treated with intravenous alteplase (IV tPA) using non-contrast head CT (NCHCT), if they meet all other standard criteria. METHODS:The SAfety of Intravenous thromboLytics in stroke ON awakening (SAIL ON) was a prospective, open-label, single treatment arm, pilot safety trial of standard dose IV tPA in patients who presented with stroke symptoms within 0-4.5 hours of awakening. From January 30, 2013, to September 1, 2015, twenty consecutive wakeup stroke patients selected by NCHCT were enrolled. The primary outcome was symptomatic intracerebral hemorrhage (sICH) in the first 36 hours. Secondary outcomes included NIH stroke scale (NIHSS) at 24 hours; and modified Rankin Score (mRS), NIHSS, and Barthel index at 90 days. RESULTS:The average age was 65 years (range 47-83); 40% were women; 50% were African American. The average NIHSS was 6 (range 4-11). The average time from wake-up to IV tPA was 205 minutes (range 114-270). The average time from last known well to IV tPA was 580 minutes (range 353-876). The median mRS at 90 days was 1 (range 0-5). No patients had sICH; two of 20 (10%) had asymptomatic ICH on routine post IV tPA brain imaging. CONCLUSIONS:Administration of IV tPA was feasible and may be safe in wakeup stroke patients presenting within 4.5 hours from awakening, screened with NCHCT. An adequately powered randomized clinical trial is needed. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov NCT01643902.

Published
2018
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2. Safety of intravenous alteplase within 4.5 hours for patients awakening with stroke symptoms

Author

Peter M. Hill, Susan Rice, Elisabeth B. Marsh, Richard Leigh, Mustapha Saheed, Steven R. Zeiler, Mona N. Bahouth, Jennifer L. Dearborn, Karen Lane, Mario Cerdan Trevino, Victor C. Urrutia, Rafael H. Llinas, and Roland Faigle

Subjects
Male, Critical Care and Emergency Medicine, lcsh:Medicine, Pilot Projects, 030204 cardiovascular system & hematology, Pathology and Laboratory Medicine, Vascular Medicine, law.invention, Diagnostic Radiology, 0302 clinical medicine, Randomized controlled trial, law, Medicine and Health Sciences, Ethnicities, Prospective Studies, Prospective cohort study, lcsh:Science, African American people, Stroke, Aged, 80 and over, Multidisciplinary, medicine.diagnostic_test, Radiology and Imaging, Arteries, Population groupings, Middle Aged, Magnetic Resonance Imaging, Hemorrhagic Stroke, Treatment Outcome, Neurology, Anesthesia, Tissue Plasminogen Activator, Administration, Intravenous, Female, medicine.symptom, Anatomy, Research Article, Imaging Techniques, Cerebrovascular Diseases, Hemorrhage, Neuroimaging, Upon Awakening, Research and Analysis Methods, Asymptomatic, Time-to-Treatment, 03 medical and health sciences, Signs and Symptoms, Fibrinolytic Agents, Diagnostic Medicine, medicine, Humans, cardiovascular diseases, Aged, Intracerebral hemorrhage, business.industry, lcsh:R, Biology and Life Sciences, Magnetic resonance imaging, medicine.disease, Clinical trial, Cardiovascular Anatomy, Blood Vessels, lcsh:Q, People and places, business, Tomography, X-Ray Computed, Head, 030217 neurology & neurosurgery, Neuroscience
Abstract

Background Up to 25% of acute stroke patients first note symptoms upon awakening. We hypothesized that patients awaking with stroke symptoms may be safely treated with intravenous alteplase (IV tPA) using non-contrast head CT (NCHCT), if they meet all other standard criteria. Methods The SAfety of Intravenous thromboLytics in stroke ON awakening (SAIL ON) was a prospective, open-label, single treatment arm, pilot safety trial of standard dose IV tPA in patients who presented with stroke symptoms within 0–4.5 hours of awakening. From January 30, 2013, to September 1, 2015, twenty consecutive wakeup stroke patients selected by NCHCT were enrolled. The primary outcome was symptomatic intracerebral hemorrhage (sICH) in the first 36 hours. Secondary outcomes included NIH stroke scale (NIHSS) at 24 hours; and modified Rankin Score (mRS), NIHSS, and Barthel index at 90 days. Results The average age was 65 years (range 47–83); 40% were women; 50% were African American. The average NIHSS was 6 (range 4–11). The average time from wake-up to IV tPA was 205 minutes (range 114–270). The average time from last known well to IV tPA was 580 minutes (range 353–876). The median mRS at 90 days was 1 (range 0–5). No patients had sICH; two of 20 (10%) had asymptomatic ICH on routine post IV tPA brain imaging. Conclusions Administration of IV tPA was feasible and may be safe in wakeup stroke patients presenting within 4.5 hours from awakening, screened with NCHCT. An adequately powered randomized clinical trial is needed. Clinical trial registration ClinicalTrials.gov NCT01643902.

Published
2018

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