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

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

doi:10.1371/journal.pone.0197714

Victor C Urrutia, Peter Hill + Show 12 more

Open Access

https://doi.org/10.1371/journal.pone.0197714

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Journal: PloS one	Publication Date: May 22, 2018
Citations: 21	License type: CC BY 4.0

Affiliation: Johns Hopkins Medicine, Johns Hopkins University

Abstract

BackgroundUp 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.MethodsThe 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.ResultsThe 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.ConclusionsAdministration 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 registrationClinicalTrials.gov NCT01643902.

Highlights

Patients who wake up with acute stroke symptoms are typically excluded from treatment with intravenous alteplase (IV tPA), most commonly because these patients are outside of the standard time window
Administration of IV tPA was feasible and may be safe in wakeup stroke patients presenting within 4.5 hours from awakening, screened with non-contrast head CT (NCHCT)
Inc. provided funding for the clinical trial (SAIL ON), which is the focus of this manuscript

Summary

Introduction

Patients who wake up with acute stroke symptoms are typically excluded from treatment with intravenous alteplase (IV tPA), most commonly because these patients are outside of the standard time window. 73% of acute ischemic stroke patients were excluded from consideration for IV tPA within 3 hours, due to an elapsed time window; 24% of these patients had an uncertain time of symptom onset.[1] Patients may have an uncertain or unwitnessed time of onset due to lack of ability or a witness to communicate time of last known well (LKW), or because symptoms are discovered upon awakening. Fink et al.[2] and Nadeau et al.[3] found that 13% to 27% of patients with acute stroke wake up with symptoms. Administration of IV tPA in wakeup stroke patients, if found to be safe and effective, could result in improved outcomes of these patients, and reduce health care costs.[5]

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