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. 2018 Aug 21;2018(8):CD010995. doi: 10.1002/14651858.CD010995.pub2

Michel 2012.

Methods Randomised, double‐blinded, placebo‐controlled pilot trial
Participants 12 participants with a supratentorial stroke of unknown onset in the middle cerebral artery territory and significant volume of at‐risk tissue on perfusion computed tomography.
9 of the participants had wake‐up stroke, and 3 had a non‐wake‐up stroke of unknown onset. The study authors contributed unpublished data on the 9 participants with wake‐up stroke.
Interventions
  • Intravenous tissue plasminogen activator (alteplase) 0.9 mg/kg body weight up to a maximum of 90 mg, 10% as bolus, 90% over 1 hour as infusion

  • Matching placebo

Outcomes Primary outcome: feasibility of study
Secondary outcome: mRS 0 to 2 at 90 days' follow‐up
Notes Principal Investigator: Patrik Michel, University of Lausanne, Lausanne, Switzerland
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table generated by independent pharmacist
Allocation concealment (selection bias) Low risk Enrolment of participants and allocation performed by blinded physician.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Placebo controlled
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinded outcome assessment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No loss to follow‐up
Selective reporting (reporting bias) Low risk No selective reporting
Other bias Unclear risk None found.

mRS: modified Rankin Scale