Thrombolysis No Riskier in Children Who Have a Stroke

Allison Shelley

February 24, 2012

February 24, 2012 — Children with ischemic stroke who are treated with thrombolysis are at no greater risk for complications than adults, a new study suggests.

The preliminary work is being released in advance of the American Academy of Neurology's 64th Annual Meeting, where it will be presented in April in New Orleans, Louisiana.

"More research is needed to determine whether the drugs are as effective in preventing disability from stroke in children as they are in adults," lead investigator Amer Alshekhlee, MD, from St. Louis University in Missouri, said in a news release.

Using data from the national Kids' Inpatient Database, investigators looked at 9367 children admitted with acute ischemic stroke. Of these, just 0.8% received thrombolysis.

The treated children were older than the rest of the cohort, with an average age of 13 compared with 8 years.

Investigators assessed safety outcomes associated with treatment. They used multivariate logistic regression analyses to evaluate covariates with hospital mortality and intracerebral hemorrhage.

The unadjusted analysis showed higher hospital mortality and intracerebral hemorrhage rates in the thrombolysis group. The 4% hemorrhage rate in the children who received thrombolytic therapy was higher than the 0.38% rate in children who did not receive the therapy; however, these numbers are similar to the rate seen in adults who receive treatment.

Table 1. Unadjusted Analysis

Outcome Thrombolysis (%) No Thrombolysis (%) P Value
Hospital mortality 12.0 6.2 .03
Intracerebral hemorrhage 4.0 0.38 .003


In contrast, the adjusted numbers suggest that intracerebral hemorrhage, but not thrombolysis, was associated with higher hospital mortality. However, thrombolysis use was still predictive of intracerebral hemorrhage, with an odds ratio of 4.28 (95% confidence interval, 1.30 - 14.0).

Table 2. Adjusted Analysis

Intracerebral Hemorrhage Odds Ratio (95% Confidence Interval)
Hospital mortality 3.42 (1.95 - 5.99)
Thrombolysis use 1.77 (086 - 3.64)


"Children who received thrombolytic therapy were no more likely to die following the stroke than those who did not receive the therapy," the authors report, although they acknowledge there is limited information about safety in large pediatric samples and the efficacy of thrombolysis in children has yet to be established.

Asked by Medscape Medical News to comment on the findings, Bruce Cohen, MD, a spokesperson for the American Academy of Neurology, said this is a limited study that sets the stage for a randomized clinical trial. Dr. Cohen is a child neurologist at the Akron Children's Hospital in Ohio.

"This will be challenging because stroke is extraordinarily rare in children so there are very few cases even at major medical centers," Dr. Cohen said. Large studies will require national coordinated efforts, and recruiting kids will be more challenging than adults, he noted.

"Within a 4.5-hour window, the family will have had to recognize the problem and taken the child to the emergency room, the hospital will have to diagnose the stroke, sedate the child, conduct magnetic resonance imaging, have a radiologist read the scan, and administer thrombolysis when appropriate."

The process, Dr. Cohen acknowledged, is challenging in adults and will be even more so in children.

"I think most neurologists would be very hesitant to administer thrombolysis to kids outside of a clinical study, and this is appropriate given how little we know at this time."

The investigators have disclosed no relevant financial relationships.

The American Academy of Neurology 64th Annual Meeting. Abstract #2557. First results released February 17, 2012.


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