At a glance
ClinicalIndex Comparison Record- ✓Children aged 2–7.99 years
- ✓Diagnosed with Hb SS or Hb Sβ0 thalassemia, confirmed by hemoglobin electrophoresis and complete blood count
- ✓Influenza vaccination during the previous year or planned before the upcoming flu season
- ✓Evidence of past varicella infection or immunization
- ✕Prior history of overt stroke or cerebral hemorrhage
- ✕Known allergy or allergic reaction to aspirin
- ✕History of Reye's syndrome
- ✕Diagnosis of G6PD deficiency or von Willebrand disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Aspirin Prophylaxis in Sickle Cell Disease
In Brief
A Phase 1 clinical trial evaluating aspirin for Sickle Cell Disease. Completed, enrolled 11 participants.
Detailed Summary
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.
Study Details
Timeline
Interventions
81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.