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

• DOI: 10.1371/journal.pone.0197714
• Publication Date: 2018-05-22T13:26:38Z
• Authors: 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; Rafael H. Llinas
• Keywords: Stroke

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