Study Examines Safety of Stroke Treatment in Children

Thrombolytic drugs appear to be as safe for children with acute ischemic stroke as they are for adults, based on an analysis of more than 9,000 patients in the Kids’ Inpatient Database.

Overall, 4% of the children in the database who got the clot-busting drugs had a brain hemorrhage, which was not significantly different than the 6% rate seen in adults with similar treatment, according to Dr. Amer Alshekhlee, a neurology fellow at the St. Louis University.

The Kids Inpatient Database contains data on 3 million pediatric hospital stays from 1997 through 2009. Dr. Alshekhlee identified 9,367 children who were treated in hospitals for acute ischemic stroke. Only 75 of those – less than 1% – received thrombolysis.

The rate was not unexpectedly low, Dr. Alshekhlee, said in an interview. In fact, he said, some reviews have suggested avoiding thrombolytic treatment for children altogether.

"Children are not getting the treatment because the treatment is not recommended for them. The rate of using thrombolysis is also low in adults, about 2%, but this rate in children is even lower."

In the database, treated children were significantly older than the untreated (mean 13 years vs. 8 years).There were no significant demographic differences in sex, race, or family income.

An unadjusted analysis showed that treated children had a significantly greater incidence of both intracranial hemorrhage (4.0% vs. 0.38 %) and intracranial hemorrhage and in-hospital mortality combined (12% vs. 6%).

In a fully adjusted model, children who received thrombolysis had significantly greater odds of developing a brain bleed than were untreated children (odds ratio, 4.3), and those who did have a bleed had almost three and a half times greater odds of dying (OR, 3.4). However, thrombolysis itself was not associated with any significant increase in mortality.

Dr. Alshekhlee’s review of the database didn’t examine functional outcomes among the children who received thrombolytic medications.

Although the data used in the review are several years old, Dr. Alshekhlee said they probably accurately reflect today’s thrombolytic treatment in children.

From a practical standpoint, the study shows that the drugs are relatively safe for children, but can’t be construed as a practice changer, coauthor Dr. Salvador Cruz-Flores said in an interview.

"In the absence of any other alternative therapy for kids with severe stroke, perhaps physicians facing the situation should consider using it, but that will require informing parents of the uncertainty of its efficacy in the population and acknowledging the gap in knowledge we have," said Dr. Cruz-Flores, director of the Souers Stroke Institute at Saint Louis University.

The investigators are scheduled to present the full results of the study in late April at the annual meeting of the American Academy of Neurology.

The review was conducted without outside funding. Neither investigator had any relevant financial disclosures.

Thrombolytic drugs appear to be as safe for children with acute ischemic stroke as they are for adults, based on an analysis of more than 9,000 patients in the Kids’ Inpatient Database.

Overall, 4% of the children in the database who got the clot-busting drugs had a brain hemorrhage, which was not significantly different than the 6% rate seen in adults with similar treatment, according to Dr. Amer Alshekhlee, a neurology fellow at the St. Louis University.

The Kids Inpatient Database contains data on 3 million pediatric hospital stays from 1997 through 2009. Dr. Alshekhlee identified 9,367 children who were treated in hospitals for acute ischemic stroke. Only 75 of those – less than 1% – received thrombolysis.

The rate was not unexpectedly low, Dr. Alshekhlee, said in an interview. In fact, he said, some reviews have suggested avoiding thrombolytic treatment for children altogether.

"Children are not getting the treatment because the treatment is not recommended for them. The rate of using thrombolysis is also low in adults, about 2%, but this rate in children is even lower."

In the database, treated children were significantly older than the untreated (mean 13 years vs. 8 years).There were no significant demographic differences in sex, race, or family income.

An unadjusted analysis showed that treated children had a significantly greater incidence of both intracranial hemorrhage (4.0% vs. 0.38 %) and intracranial hemorrhage and in-hospital mortality combined (12% vs. 6%).

In a fully adjusted model, children who received thrombolysis had significantly greater odds of developing a brain bleed than were untreated children (odds ratio, 4.3), and those who did have a bleed had almost three and a half times greater odds of dying (OR, 3.4). However, thrombolysis itself was not associated with any significant increase in mortality.

Dr. Alshekhlee’s review of the database didn’t examine functional outcomes among the children who received thrombolytic medications.

Although the data used in the review are several years old, Dr. Alshekhlee said they probably accurately reflect today’s thrombolytic treatment in children.

From a practical standpoint, the study shows that the drugs are relatively safe for children, but can’t be construed as a practice changer, coauthor Dr. Salvador Cruz-Flores said in an interview.

"In the absence of any other alternative therapy for kids with severe stroke, perhaps physicians facing the situation should consider using it, but that will require informing parents of the uncertainty of its efficacy in the population and acknowledging the gap in knowledge we have," said Dr. Cruz-Flores, director of the Souers Stroke Institute at Saint Louis University.

The investigators are scheduled to present the full results of the study in late April at the annual meeting of the American Academy of Neurology.

The review was conducted without outside funding. Neither investigator had any relevant financial disclosures.

Thrombolytic drugs appear to be as safe for children with acute ischemic stroke as they are for adults, based on an analysis of more than 9,000 patients in the Kids’ Inpatient Database.

Overall, 4% of the children in the database who got the clot-busting drugs had a brain hemorrhage, which was not significantly different than the 6% rate seen in adults with similar treatment, according to Dr. Amer Alshekhlee, a neurology fellow at the St. Louis University.

The Kids Inpatient Database contains data on 3 million pediatric hospital stays from 1997 through 2009. Dr. Alshekhlee identified 9,367 children who were treated in hospitals for acute ischemic stroke. Only 75 of those – less than 1% – received thrombolysis.

The rate was not unexpectedly low, Dr. Alshekhlee, said in an interview. In fact, he said, some reviews have suggested avoiding thrombolytic treatment for children altogether.

"Children are not getting the treatment because the treatment is not recommended for them. The rate of using thrombolysis is also low in adults, about 2%, but this rate in children is even lower."

In the database, treated children were significantly older than the untreated (mean 13 years vs. 8 years).There were no significant demographic differences in sex, race, or family income.

An unadjusted analysis showed that treated children had a significantly greater incidence of both intracranial hemorrhage (4.0% vs. 0.38 %) and intracranial hemorrhage and in-hospital mortality combined (12% vs. 6%).

In a fully adjusted model, children who received thrombolysis had significantly greater odds of developing a brain bleed than were untreated children (odds ratio, 4.3), and those who did have a bleed had almost three and a half times greater odds of dying (OR, 3.4). However, thrombolysis itself was not associated with any significant increase in mortality.

Dr. Alshekhlee’s review of the database didn’t examine functional outcomes among the children who received thrombolytic medications.

Although the data used in the review are several years old, Dr. Alshekhlee said they probably accurately reflect today’s thrombolytic treatment in children.

From a practical standpoint, the study shows that the drugs are relatively safe for children, but can’t be construed as a practice changer, coauthor Dr. Salvador Cruz-Flores said in an interview.

"In the absence of any other alternative therapy for kids with severe stroke, perhaps physicians facing the situation should consider using it, but that will require informing parents of the uncertainty of its efficacy in the population and acknowledging the gap in knowledge we have," said Dr. Cruz-Flores, director of the Souers Stroke Institute at Saint Louis University.

The investigators are scheduled to present the full results of the study in late April at the annual meeting of the American Academy of Neurology.

The review was conducted without outside funding. Neither investigator had any relevant financial disclosures.