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Thrombolysis in Pediatric Stroke Study

Stroke is an important acute neurological condition in children with an annual incidence ranging from 2.3 to 13 per 100 000 children.1–3 Although most children who experience stroke do not die of the acute disorder, the consequences of the brain injury are amortized during the lengthy life span that follows.4–8 The reduction potential in lifelong morbidity by timely and effective intervention with a thrombolytic agent, such as tissue-type plasminogen activator (tPA), in children with acute arterial ischemic stroke (AIS) constituted the core rationale for the study of tPA treatment of acute AIS in children. The perceived high potential for benefit after treatment justified assumption of risk for intracranial hemorrhage (ICH) after its use.9 Because in adults, the risk of hemorrhage after tPA use was thought to be related to infarct volume; this principle was assumed for children. The known developmental trajectory of the fibrinolytic system includes lower levels of endogenous tPA and higher levels of plasminogen activator inhibitor-1 in young children than are found in adults and warranted a dose-finding study beginning at doses lower than that used in adults with incremental increase through the currently used adult dose of 0.9 mg/kg and careful assessment of tPA pharmacokinetics.10

Currently, information on children treated with tPA consists of case reports, small case series, and hospital database documentation. Best practice for the treatment of children with acute stroke has received little rigorous study. Clinical approach varies widely among centers and reflects a dearth of research on which to base treatment protocols. Although tPA is not approved for use in childhood stroke, ≤2% of children with acute stroke are reported to have been treated with tPA in the United States, despite lack of safety and efficacy data.11–14

In 2010, the National Institute …