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 STOP
II Study
STOP II was initiated in 2000 to look at how long
transfusion has to be continued for primary stroke prevention.
Twenty-eight
sites are involved in this
controlled clinical trial. A total of 100 patients are expected to be
randomized to either continue transfusion (standard therapy) or withdraw
from transfusions (test therapy). Children eligible for the study have at
least 30 months of chronic blood transfusion, TCD testing which indicate
normal risk, and magnetic resonance angiography which are free of severe
stenosis. The hypothesis is that no more than 50% of the patients removed
from transfusion will have either stroke or reversion to abnormal TCD. Study
endpoints are stroke, abnormal TCD or repeated inadequate TCD's.
Any child whose TCD reverts to abnormal will return to clinical care, which
may include chronic transfusion for stroke prevention.
The results of STOP II are eagerly awaited. Some physicians are reluctant to
adopt the STOP stroke prevention strategy because of the indefinite duration
of transfusion and cumulative problems of long-term transfusion. |
