The objective of this manuscript is to describe the innovative method used to process and adjudicate imaging studies for an international trial with a primary endpoint that includes neuroimaging. Each child undergoes a screening magnetic resonance imaging (MRI) of the brain to detect the presence of silent cerebral infarct-like lesions, a pre-randomization (baseline) MRI and exit MRI to determine if there are new or enlarged cerebral infarcts, using a designated, prospective imaging protocol. The SIT Trial is scheduled to enroll approximately 1,880 children with sickle cell disease from 29 clinical sites in the United States, Canada, UK, and France.
The Silent Cerebral Infarct Multicenter Transfusion (SIT) Trial is a multi-institutional intervention trial in which children with silent cerebral infarcts are randomized to receive either blood transfusion therapy or observation (standard care) for 36 months.
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