Thrombolysis in acute childhood stroke: design and challenges of the thrombolysis in pediatric stroke clinical trial. Neuroepidemiology 2009;32(4):279-86
Date
02/19/2009Pubmed ID
19223687DOI
10.1159/000203076Scopus ID
2-s2.0-60449113087 (requires institutional sign-in at Scopus site) 93 CitationsAbstract
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.
Author List
Amlie-Lefond C, Chan AK, Kirton A, deVeber G, Hovinga CA, Ichord R, Stephens D, Zaidat OO, Thrombolysis in Pediatric Stroke (TIPS) InvestigatorsMESH terms used to index this publication - Major topics in bold
AdolescentBayes Theorem
Brain Ischemia
Child
Child, Preschool
Cohort Studies
Drug Dosage Calculations
Humans
Injections, Intra-Arterial
Injections, Intravenous
Stroke
Thrombolytic Therapy
Time Factors
Tissue Plasminogen Activator
