Thrombolysis in acute childhood stroke: design and challenges of the thrombolysis in pediatric stroke clinical trial.
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.


METHODS
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.


CONCLUSIONS
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.
Amlie-Lefond
Catherine
C
Department of Neurology, Medical College of Wisconsin, Milwaukee, Wisc. 53226, USA. Klefond@mcw.edu
Chan
Anthony K C
AK
Kirton
Adam
A
deVeber
Gabrielle
G
Hovinga
Collin A
CA
Ichord
Rebecca
R
Stephens
Derek
D
Zaidat
Osama O
OO
D000293:Adolescent; D001499:Bayes Theorem; D002545:Brain Ischemia / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D054796:Drug Dosage Calculations; D006801:Humans; D007269:Injections, Intra-Arterial; D007275:Injections, Intravenous; D020521:Stroke / Q000188:drug therapy*; D015912:Thrombolytic Therapy / Q000379:methods*; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000627:therapeutic use
D010959:Tissue Plasminogen Activator