Using a Pediatric Thrombolysis Trial as a Model for Development of Pediatric...

Updated:Jun 27,2014
AHA Science News


Using a Pediatric Thrombolysis Trial as a Model for Development of Pediatric Acute Stroke Centers

Emergence of the Primary Pediatric Stroke Center: Impact of the Thrombolysis in Pediatric Stroke Trial
Timothy J. Bernard, Michael J. Rivkin, Kelley Scholz, Gabrielle deVeber, Adam Kirton, Joan Cox Gill, Anthony K. Chan, Collin A. Hovinga, Rebecca N. Ichord, James C. Grotta, Lori C. Jordan, Susan Benedict, Neil R. Friedman, Michael M. Dowling, Jorina Elbers, Marcela Torres, Sally Sultan, Dana D. Cummings, Eric F. Grabowski, Hugh J. McMillan, Lauren A. Beslow, Catherine Amlie-Lefond, on behalf of the Thrombolysis in Pediatric Stroke Study
Stroke. 2014; STROKEAHA.114.004919 Published online before print June 10, 2014, doi: 10.1161/?STROKEAHA.114.004919

Highlights from the Study

 
  • Currently there are few hospitals capable of treating acute pediatric stroke in the manner in which adults are treated for acute stroke (Primary Stroke Centers – [PSCs] criteria).
  • This paper outlines the inclusion of best practice modalities in order to develop high-level stroke centers for pediatric stroke based on requirements of centers for participation in the TIPS trial. The TIPS Trial (Thrombolysis in Pediatric Stroke) was a multinational, NIH/NINDS---sponsored safety and dose-finding trial of IV rt-PA in children with acute (arterial) ischemic stroke to determine the maximal, safe dose of IV rt-PA (3 doses: 0.75/kg, 0.9 mg/kg and 1.0 mg/kg in children aged 2-17 years, within a treatment window of 4.5 hours of stroke symptoms onset). The authors of this paper used information from questionnaires from the TIPS (Thrombolysis in Pediatric Stroke trial) to determine readiness to identify and treat children with acute ischemic stroke.
  • TIPS trial readiness to treat pediatric stroke was modeled after adult PSCs.
  • Assessment of readiness to participate in the TIPS trial included:
    1. the development of hospital-wide stroke systems of care (including stroke triage);
    2. 24/7 day-per-week pediatric stroke coverage (ability to deliver IV rt-PA 24/7 days per week);
    3. emergency department and pediatric ICU protocols;
    4. development of outpatient care for pediatric stroke (stroke clinic and inclusion of the multidisciplinary team in caring for pediatric stroke –neurologists, nursing, neurosurgeons, cardiologists, hematologists, neuroradiologists, rheumatologists, neuropsychologists, rehabilitation specialists, psychologists, vascular geneticists, and social workers); and 
    5. readiness for the acquisition of acute and follow-up neuroimaging, including MRI, with the capability to sedate the pediatric patient.
  • In 2009 (right before TIPS funding), less than 50% of sites had any of these processes and procedures in place to conduct the acute pediatric stroke trial.
  • Between 2010 and 2013, all of the processes and procedures required for a TIPS site were apparent in >80% of potential TIPS sites.  
  • Before 2010, only 10% of site Principal Investigators had NIHSS certification; in 2013, 100% had NIHSS certification.  
  • The TIPS trial impacted study sites for pediatric stroke preparedness to diagnose and treat children with ischemic stroke.  
  • Study centers developed stroke protocols in preparation for the TIPS study. Study preparedness is used as a model for high-quality and best-practice care for rapid management of the pediatric stroke patient.  
  • While the TIPS trial was stopped prematurely, the information within this paper helps define what resources and systems of care would look like for the pediatric stroke patient.

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