Clinical trials needed for paediatric stroke

TORONTO (December 29, 2005) - Researchers at The Hospital for Sick Children
(SickKids), Stollery Children's Hospital and Chedoke McMaster have advised that
randomized clinical trials are urgently needed to equip diagnosing physicians
with the most effective treatment options for paediatric stroke.
This research is published in the January 2006 issue of the journal Stroke.

"There is a lot of uncertainty for clinicians when identifying the best
treatment options for different types of paediatric stroke, as there is little
to no evidence from clinical trials to support treatment decisions,"
said Dr. Gabrielle deVeber, the study's principal investigator, a paediatric
neurologist and scientist at SickKids and an associate professor of Paediatrics
at the University of Toronto. "By compiling data on the largest number of
children with stroke and the clinicians treating them, we were able to identify
the most significant treatment issues facing physicians when dealing with
paediatric stroke."

From January 1995 to January 1, 2005 physicians worldwide consulted the
1-800-NOCLOTS toll-free paediatric stroke telephone consultation service.
The consultation service, run out of SickKids in Toronto, Stollery Children's
Hospital in Edmonton and the Children's Hospital at Chedoke McMaster in Hamilton
provided telephone support and treatment suggestions to physicians dealing with
paediatric stroke. The paediatric neurologists and haematologists operating the
line documented caller and patient characteristics, antithrombotic treatments
and caller's questions for entry into a computerized database.

"While we were collecting data, physicians were also provided with
patient-specific support by a consultation service through the use of an
annually updated published paediatric stroke protocol," said Dr. deVeber, who is
also director of the Children's Stroke Program at SickKids.

Stroke consults were completed on 1,065 children from birth to 18 years of age
during the nine-year study. The majority of the calls were from the United
States and 54 per cent of the consult patients were male and 16 per cent were
newborns. Children were diagnosed with arterial ischemic stoke (AIS), where a
blockage in the arteries or veins inhibits the supply of blood flow to the
brain, or cerebral sinovenous thrombosis (CSVT), a type of stroke that occurs in
children due to blood clots blocking the brain's venous flow.

Dr. deVeber previously discovered that sinovenous thrombosis accounts for 20 per
cent of all ischemic strokes in children. The incidence of this disorder in the
childhood population is at least one per 200,000 children and 1 in 10,000
newborns per year. The other 80 per cent of ischemic strokes are arterial.

"Based on our findings with the consults, it is clear that research is urgently
needed in paediatric stroke to provide treatment guidance for clinical
settings," added Dr. deVeber. "It is very important that this research
investigate the unique challenges and potential treatment options for the
different types of stroke, and that newborns be evaluated separately from older
infants and children."

Strokes are usually associated with the very old, not the very young. Data
obtained from adult stroke trials are not directly applicable to infants and
children though because of age-related differences in the coagulation, vascular,
and neurological systems as well as major differences in the risk factors and
outcomes from stroke.

Strokes occur in children more frequently than brain tumours, at a rate of three
per 100,000 children in Canada annually. In the past five years, SickKids has
treated 500 children with stroke and sees three to five new cases a week. In
addition, a weekly stroke clinic follows over 600 children with stroke.

Childhood stroke symptoms are similar to those of adult stroke and include a
severe headache, sudden weakness of one side of the body, speech difficulties,
eye movement problems and numbness. When symptoms of stroke occur in children
they should be seen urgently as CT or MRI scans and critical medical treatment
may be needed to prevent further damage to the brain.

Other members of the research team were Dr. Patricia Massicotte, Dr. Stefan
Kuhle and Lesley Mitchell of Stollery Children's Hospital, Dr. Anthony K.
Chan of Children's Hospital at Chedoke, and Dr. Maureen Andrew and Margaret
Adams of SickKids.

This research was supported by the Heart and Stroke Foundation of Canada, the
Canadian Institutes of Health Research, Baxter BioScience and SickKids
Foundation.

The Hospital for Sick Children, affiliated with the University of Toronto, is
Canada's most research-intensive hospital and the largest centre dedicated to
improving children's health in the country. Its mission is to provide the best
in family-centred, compassionate care, to lead in scientific and clinical
advancement, and to prepare the next generation of leaders in child health. For
more information, please visit www.sickkids.ca.

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For more information, please contact:
Laura Greer, Public Affairs
The Hospital for Sick Children
(416) 813 5046
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