A study to determine whether the drug hydroxyurea prevents stroke in children with sickle cell anemia and iron overload has been halted early because the drug was unlikely to prove more effective than the current standard treatment of blood transfusions, the U.S. National Heart, Lung, and Blood Institute said Friday.
Hydroxyurea is known to prevent complications of sickle cell disease in adults. This 26-site clinical trial included 133 children, ages 5 to 18, who had already suffered a stroke and had received blood transfusions for at least 18 months and had high levels of iron.
"Protecting our participants is an important factor in determining whether to stop a trial," Dr. Susan B. Shurin, acting director of the NHLBI, said in an agency news release. "When an experimental treatment fails to meet its predetermined goals, it is best to return participants to standard treatment as soon as possible."
About 10 percent of children with sickle cell disease suffer a stroke, which puts them at high risk for subsequent stroke unless they receive preventive treatment, the agency said.
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