Stroke Prevention in Nigeria 2 Trial

[...] at least 7 years of age; Two TCD flow velocity readings of >200or 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 sa [...]

Inclusion Criteria: The inclusion criteria for the SPRING-2 Trial will consist of 1) diagnosis: Diagnosis of HbSS or HbSB0 confirmed by high-performance liquid chromatography (HPLC); 2) informed Informed consent from the parent/legal guardian and assent from the patient at least 7 years of age; 3) two Two TCD flow velocity readings of >200 cm/sec and < 220 cm/sec [...] erformed on the same day so treatment can start immediately; 4) age Age between 5 and 12 years (assessment can take place up until [...] ncludes the peak age of onset of strokes in SCA, ~ 6 yo; and 5) ability Ability to swallow the hydroxyu [...] [...]

[...] lation an unaffordable undertaking in low-income countries. We propose aThis multicenter open-label, single-arm type I hybrid trial towill assess the effectiveness of Hydroxyurea therapy for primary [...] n children with sickle cell anemia (SCA) living in Nigeria. OurA team justrecently completed a double-blind, parallel-group phase III randomized controlled trial (SPRING), whereinvolved we comparedcomparing low-dose to moderate-dose hydroxyurea for primary stroke pr [...] p. A non-inferiority test with an overall sample size of 220 participants will achieve 91% power at a 0.050 significance level to det [...] eri [...]