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Thrombolysis in Acute Childhood Stroke: Design and Challenges of the Thrombolysis in Pediatric Stroke Clinical TrialAmlie-Lefond C.a · Chan A.K.C.d · Kirton A.e · deVeber G.f · Hovinga C.A.b · Ichord R.c · Stephens D.f · Zaidat O.O.a
aDepartment of Neurology, Medical College of Wisconsin, Milwaukee, Wisc., bDepartments of Clinical Pharmacy and Pediatrics, University of Tennessee Health Science Center, Memphis, Tenn., and cDepartment of Neurology and Pediatrics, Children’s Hospital of Philadelphia, Philadelphia, Pa., USA; dDepartment of Pediatrics, McMaster University, Hamilton, Ont., eDepartment of Pediatrics and Clinical Neuroscience, University of Calgary, Calgary, Alta., and fDepartment of Neurology, Hospital for Sick Children, Toronto, Ont., Canada Corresponding Author
Catherine Amlie-Lefond, MD
Medical College of Wisconsin, Department of Neurology
9200 W Wisconsin Ave
Milwaukee, WI 53226 (USA)
Tel. +1 414 266 7545, Fax +1 414 266 3466, E-Mail Klefond@mcw.edu
Background: Although tissue plasminogen activator (tPA) has revolutionized the treatment of acute ischemic stroke in adults, no thrombolysis trials in childhood stroke have been conducted. Experience in adults cannot be applied to children due to fundamental age-related differences in coagulation systems, stroke pathophysiology and neuropharmacology. Obstacles to acute treatment trials in childhood stroke include delays in diagnosis and minimizing risk in a vulnerable population. Study Design: Thrombolysis in Pediatric Stroke (TIPS) is an international multicenter study to assess the safety of intravenous tPA within 0–3 h and intra-arterial tPA within 3–6 h of onset of arterial ischemic stroke in childhood. Through the International Pediatric Stroke Study, 30 international centers will enroll a total of 48 patients: 24 will be treated with intravenous tPA (0.6, 0.75, 0.9, and 1.0 mg/kg) using the classical dose-finding method, and 24 will be treated with intra-arterial tPA (maximum 0.2, 0.3, 0.4, and 0.5 mg/kg) using a Bayesian dose-finding method. Conclusion: The TIPS trial will be the first clinical trial exploring the safety and feasibility of systemic and local thrombolytic therapy in childhood stroke and the obstacles in conducting such a trial.
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