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Design of the silent cerebral infarct transfusion (SIT) trial
James F Casella1, Allison A King, Bruce Barton
1Pediatric Hematology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21205, USA. jcasella@jhmi.edu
Insights
Prophylactic blood transfusions may significantly reduce neurological damage in children with sickle cell anemia and silent cerebral infarcts. This trial investigates the effectiveness of transfusions in preventing strokes and further brain injury.
Area of Science:
- Neurology
- Hematology
- Pediatrics
Background:
- Silent cerebral infarct (SCI) is a common neurological complication in children with sickle cell anemia (SCA), affecting about 22% of this population.
- SCI is associated with significant neurological disease in children with SCA.
Purpose of the Study:
- To determine if blood transfusion therapy reduces further neurological morbidity in children with SCI.
- To quantify the benefit of transfusion therapy in preventing strokes and new or progressive cerebral infarcts.
Main Methods:
- The Silent Cerebral Infarct Transfusion (SIT) Trial is a multicenter study involving 204 children with SCA and SCI.
- Participants are randomized to receive either prophylactic blood transfusions or observation.
- Magnetic resonance imaging (MRI) and neurological examinations are used to assess outcomes, alongside cognitive testing.
Main Results:
- The study hypothesizes that prophylactic blood transfusion therapy will reduce the rate of subsequent overt strokes or new/progressive cerebral infarcts by at least 86%.
- The trial is powered to detect this effect, accounting for dropout and crossover rates.
Conclusions:
- The SIT Trial has the potential to alter standard care for children with SCA and SCI.
- Findings may lead to reduced neurological morbidity in this vulnerable pediatric population.
Background:
Silent cerebral infarct (SCI) is the most common cause of serious neurological disease in sickle cell anemia (SCA), affecting approximately 22% of children. The goal of this trial is to determine whether blood transfusion therapy will reduce further neurological morbidity in children with SCI, and if so, the magnitude of this benefit.
Procedure:
The Silent Cerebral Infarct Transfusion (SIT) Trial includes 29 clinical sites and 3 subsites, a Clinical Coordinating Center, and a Statistical and Data Coordinating Center, to test the following hypothesis: prophylactic blood transfusion therapy in children with SCI will result in at least an 86% reduction in the rate of subsequent overt strokes or new or progressive cerebral infarcts as defined by magnetic resonance imaging (MRI) of the brain. The intervention is blood transfusion versus observation. Two hundred and four participants (102 in each treatment assignment) will ensure 85% power to detect the effect necessary to recommend transfusion therapy (86% reduction), after accounting for 10% drop out and 19% crossover rates. MRI examination of the brain is done at screening, immediately before randomization and study exit. Each randomly assigned participant receives a cognitive test battery at study entry, 12-18 months later, and study exit and an annual neurological examination. Blood is obtained from all screened participants for a biologic repository containing serum and a renewable source of DNA.
Conclusion:
The SIT Trial could lead to a change in standard care practices for children affected with SCA and SCI, with a consequent reduction in neurological morbidity.
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