San Diego, CA, Dec. 5, 2004 The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has stopped early a clinical trial studying whether children with sickle cell anemia at high risk for stroke could at some point after a minimum of 30 months (range 30-91 months) safely stop receiving the periodic blood transfusions that prevent strokes. The study found a return to high risk of stroke in children who stopped receiving the transfusions. The NHLBI is issuing a clinical alert on the study's results to inform physicians who treat children with sickle cell anemia.

The alert advises physicians that stopping transfusions cannot be recommended. The document urges them to carefully discuss with patients and their families the stroke prevention benefits of continuing periodic transfusions as well as the risks of these transfusions, which can include such long-term side effects as iron overload. Management of these side effects should also be discussed, according to the alert.

The results of the Stroke Prevention Trial II (STOP II) are being presented in San Diego today as a special "late-breaking" announcement at the annual meeting of the American Society of Hematology (ASH). To further inform physicians, the NHLBI is posting the alert on the National Library of Medicine's Clinical Alert and Advisories Web page. STOP II investigators are notifying patients enrolled in the study and their families.

STOP II, which began in 2000, expected to recruit 100 patients age 2 to 18 over 6 years. When the study was stopped 2 years early on November 10, 79 patients had been enrolled. At the time the study was halted, 14 of the 41 patients who had been randomly assigned to stop transfusions reverted to high risk of stroke as measured by a special ultrasound technique and 2 patients had suffered a stroke. There were no strokes or reversions to high stroke risk in the group that continued with transfusions.

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Contact: NHLBI Communications Office
301-496-4236
NIH/National Heart, Lung, and Blood Institute
5-Dec-2004

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