Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II: A Multicenter, Open-label, Single-arm Type I Hybrid Clinical Trial
The primary goal of this study is to complete a multicenter single-arm, type I hybrid trial to assess the effectiveness of hydroxyurea therapy for primary stroke prevention in high-risk children with sickle cell anemia (SCA) living in Nigeria in routine care settings.
‣ The inclusion criteria for the SPRING-2 Trial will consist of:
⁃ Diagnosis of HbSS or HbSB0 confirmed by high-performance liquid chromatography (HPLC);
⁃ Informed consent from the parent/legal guardian and assent from the patient at least 7 years of age;
⁃ Two TCD flow velocity readings of \>or equal to180 cm/sec and \< 220 cm/sec or one TCD velocity reading \> or equal to 220 cm/sec; typically the repeat TCD is performed on the same day so treatment can start immediately;
⁃ Age between 5 and 12 years (assessment can take place up until the 13th birthday), which includes the peak age of onset of strokes in SCA, \
• 6 yo; and
⁃ Ability to swallow the hydroxyurea capsule.