What to do about pediatric stroke remains elusive

By Will Boggs MD

NEW YORK (Reuters Health) - The Thrombolysis in Pediatric Stroke (TIPS) study aimed to resolve whether thrombolytic therapy could be safe and feasible in children presenting with acute ischemic stroke. Unfortunately, the National Institutes of Health (NIH) halted the trial in December 2013 for lack of accrual.

"A primary obstacle in TIPS was the amount of time needed to build primary pediatric stroke centers able to rapidly diagnose stroke in children and provide urgent treatment," Dr. Catherine Amlie-Lefond, from Seattle Children's Hospital/University of Washington, told Reuters Health by email. "Such centers must be established, including support by institutional funding and recruitment of pediatric stroke specialists, for future studies of acute stroke in childhood."

As Dr. Amlie-Lefond and her TIPS colleagues explain in their January 22 online special report in Stroke, between the study's official start on April 20, 2012 and its closure on December 21, 2013, the 14 activated sites (of the 22 primary sites) had successfully enrolled only 1 of 93 children aged 2 to 17 years who were screened.

"Within weeks of closure of TIPS, eligible patients were identified at former TIPS sites, and continue to be identified and treated," Dr. Amlie-Lefond said. "It is paramount that future studies of acute treatment in pediatric stroke be conducted at sites that meet criteria for a Primary Pediatric Stroke Center."

"We believe that collecting standardized outcome data on children treated with (tissue-type plasminogen activator, tPA) within the safety guidelines established by the TIPS investigators is critical," she explained. "tPA continues to be administered in childhood stroke, including by former TIPS investigators, to children at their center within the consensus based guidelines established by TIPS."

"The challenges in enrolling children within hours of stroke onset were demonstrated in the TIPS trial," Dr. Amlie-Lefond explained. "The solution has been implemented across many leading children's hospitals: developing urgent care guidelines for pediatric stroke. While enrollment in pediatric tPA trials is slower than adults, it is feasible."

"Children with acute stroke are best treated at Primary Pediatric Stroke Centers with on-site specific expertise in pediatric stroke," Dr. Amlie-Lefond added. "Some of these children may be eligible for tPA based on published safety criteria, but all of them will benefit from a stroke-focused clinical program."

Dr. Sophia Sundararajan, from University Hospitals/Case Medical Center's Neurological Institute, Cleveland, Ohio, told Reuters Health, "It is very disappointing that so few children could be enrolled in this study. I think that it will be very difficult to get meaningful data on the use of tPA in children. StrokeNet, which is a new network of clinical trial sites funded by the (National Institutes of Health), may be able to make some headway in this area."

In the meantime, the question remains: How should these children be treated? "At this point there is little data to guide us," Dr. Sundararajan said. "Each case is addressed on a case-by-case basis. We need to be aware that there are a large number of stroke mimics in children and need to confirm that a suspected stroke is truly a stroke... Parents must be aware that there is no standard of care and consent to treatment."

"Childhood stroke is a relatively infrequent event," she said. "Because of this, there is often a delay in making the diagnosis, and most patients are out of the window for tPA before the diagnosis is made. If we are to get answers on the best way to manage these patients, it is critical that every case possible be enrolled in a trial when one is available or else we will never get clear answers to these questions."

SOURCE: http://bit.ly/1JPebxO

Stroke 2015.

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