Neuroradiology

, Volume 54, Issue 6, pp 579–588 | Cite as

Perfusion-CT guided intravenous thrombolysis in patients with unknown-onset stroke: a randomized, double-blind, placebo-controlled, pilot feasibility trial

  • Patrik Michel
  • George Ntaios
  • Marc Reichhart
  • Christian Schindler
  • Julien Bogousslavsky
  • Philip Maeder
  • Reto Meuli
  • Max Wintermark
Interventional Neuroradiology

Abstract

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 PCT-guided 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.

Keywords

Perfusion CT Thrombolysis Stroke of unknown onset 

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Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Patrik Michel
    • 1
    • 6
  • George Ntaios
    • 1
  • Marc Reichhart
    • 1
  • Christian Schindler
    • 2
  • Julien Bogousslavsky
    • 3
  • Philip Maeder
    • 4
  • Reto Meuli
    • 4
  • Max Wintermark
    • 5
  1. 1.Department of Neurology ServiceCenter Hospitalier Universitaire Vaudois and University of LausanneLausanneSwitzerland
  2. 2.Pharmacy DepartmentCenter Hospitalier Universitaire Vaudois and University of LausanneLausanneSwitzerland
  3. 3.Genolier Swiss Medical NetworkGlionSwitzerland
  4. 4.Department of RadiologyCenter Hospitalier Universitaire Vaudois and University of LausanneLausanneSwitzerland
  5. 5.Department of Radiology, Division of NeuroradiologyUniversity of VirginiaCharlottesvilleUSA
  6. 6.Neurology ServiceCentre Hospitalier Universitaire Vaudois & University of LausanneLausanneSwitzerland

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