Perfusion-CT guided intravenous thrombolysis in patients with unknown-onset stroke: a randomized, double-blind, placebo-controlled, pilot feasibility trial
- نوع فایل : کتاب
- زبان : انگلیسی
- مؤلف : Patrik Michel & George Ntaios & Marc Reichhart & Christian Schindler & Julien Bogousslavsky & Philip Maeder & Reto Meuli & Max Wintermark
- چاپ و سال / کشور: 2011
Description
Introduction Patients with unknown stroke onset are generally excluded from acute recanalisation treatments. We designed a pilot study to assess feasibility of a trial of perfusion computed tomography (PCT)-guided thrombolysis in patients with ischemic tissue at risk of infarction and unknown stroke onset. Methods Patients with a supratentorial stroke of unknown onset in the middle cerebral artery territory and significant volume of at-risk tissue on PCT were randomized to intravenous thrombolysis with alteplase (0.9 mg/kg) or placebo. Feasibility endpoints were randomization and blinded treatment of patients within 2 h after hospital arrival, and the correct application (estimation) of the perfusion imaging criteria. Results At baseline, there was a trend towards older age [69.5 (57–78) vs. 49 (44–78)years] in the thrombolysis group (n=6) compared to placebo (n=6). Regarding feasibility, hospital arrival to treatment delay was above the allowed 2 h in three patients (25%). There were two protocol violations (17%) regarding PCT, both underestimating the predicted infarct in patients randomized in the placebo group. No symptomatic hemorrhage or death occurred during the first 7 days. Three of the four (75%) and one of the five (20%) patients were recanalized in the thrombolysis and placebo group respectively. The volume of non-infarcted at-risk tissue was 84 (44–206)cm3 in the treatment arm and 29 (8–105)cm3 in the placebo arm. Conclusions This pilot study shows that a randomized PCTguided thrombolysis trial in patients with stroke of unknown onset may be feasible if issues such as treatment delays and reliable identification of tissue at risk of infarction tissue are resolved. Safety and efficiency of such an approach need to be established
Neuroradiology DOI 10.1007/s00234-011-0944-1 Received: 23 March 2011 / Accepted: 25 July 2011
