Until recently, IVT with alteplase was not approved in patients with acute ischaemic stroke aged under 18 years. Based on observational data, regulatory authorities in several countries have now approved use of IVT with alteplase in patients 16-18 years, if other Summary of Product Criteria (SmPC) are fulfilled. Regulatory authorities have requested monitoring of treatment in this age group, SITS will therefor perform a study of IVT in patients with acute ischaemic stroke aged 16-18 years. The study protocol was recently approved by the Swedish ethics committee. We encourage all SITS centres to participate in this study and interested centres can inform their paediatric department about the upcoming study.
Please contact SITS us at info@sitsinternational.org for more information.