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.
Contact: NHLBI Communications Office
NIH/National Heart, Lung, and Blood Institute