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Aspirin Prophylaxis in Sickle Cell Disease (START)
Neurologic complications secondary to cerebrovascular damage are prevalent in children with sickle cell disease. These patients experience both clinically overt cerebrovascular accidents and "silent infarctions" demonstrated by magnetic resonance imaging (MRI). They are also at risk for neurocognitive abnormalities.We hypothesize that daily, low-dose aspirin therapy will safely diminish the incidence and progression of cognitive deficits as well as the predisposition to overt and silent stroke in children with homozygous sickle cell disease (Hgb SS) or hemoglobin S Beta Zero Thalassemia (Hgb SB-0 Thal). In order to optimize the design of a future trial to test this hypothesis, we propose a pilot study to test the safety and tolerability of aspirin in young children with sickle cell disease.
Details
| Lead sponsor | University of Rochester |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 11 |
| Start date | 2005-03 |
| Completion | 2009-11 |
Conditions
- Sickle Cell Disease
Interventions
- aspirin
Primary outcomes
- Number of Serious Adverse Events — 12 months
Occurrence of individual serious adverse events and relationship to aspirin - Number of Adverse Events — 12 months
Occurrence of individual adverse events and relationship to aspirin