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Methods in Neuroepidemiology

Free Access

Thrombolysis in Acute Childhood Stroke: Design and Challenges of the Thrombolysis in Pediatric Stroke Clinical Trial

Amlie-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

Author affiliations

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

Related Articles for ""

Neuroepidemiology 2009;32:279–286

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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.

© 2009 S. Karger AG, Basel

Article / Publication Details

First-Page Preview
Abstract of Methods in Neuroepidemiology

Received: October 15, 2008
Accepted: December 08, 2008
Published online: February 18, 2009
Issue release date: April 2009

Number of Print Pages: 8
Number of Figures: 1
Number of Tables: 0

ISSN: 0251-5350 (Print)
eISSN: 1423-0208 (Online)

For additional information: http://www.karger.com/NED

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