BETHESDA, Md., June 7 (UPI) — The National Heart, Lung, and Blood Institute has stopped a trial involving recurrent stroke risk in children suffering sickle cell anemia and iron overload.
Officials at the institute, part of the National Institutes of Health, said the study, due to be completed in 2012, was stopped because evidence showed the new treatment was unlikely to prove better than the existing treatment.
The 26-site trial involved 133 participants between the ages of 5 and 18 who had already experienced a stroke. All had been receiving the standard treatment of blood transfusions for at least 18 months and high levels of iron before entering the study. Officials said without further preventive measures, the children were at high risk of another stroke, as well as life-threatening conditions due to iron overload.
Officials noted no strokes occurred in 66 participants who received the standard therapy. In contrast, seven strokes occurred in the group of 67 participants who underwent the trial regimen.
“Protecting our participants is an important factor in determining whether to stop a trial,” said Dr. Susan Shurin, NHLBI acting director. “When an experimental treatment fails to meet its predetermined goals, it is best to return participants to standard treatment as soon as possible.”
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