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Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE)
Sponsor: Children's Hospital Medical Center, Cincinnati
Summary
This study will 1) Evaluate the prevalence of elevated (conditional or abnormal) transcranial Doppler (TCD) velocities in a cross-sectional analysis of children with Sickle Cell Anemia (SCA) living in Tanzania; 2) Obtain longitudinal data on TCD velocities in this population; and 3) Measure the effects of hydroxyurea therapy on TCD velocities and associated primary stroke risk.
Official title: Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE): A Prospective Trial to Reduce Primary Stroke in Children With Sickle Cell Anaemia
Key Details
Gender
All
Age Range
2 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
202
Start Date
2019-04-24
Completion Date
2026-12-31
Last Updated
2025-07-17
Healthy Volunteers
No
Conditions
Interventions
Hydroxyurea
Hydroxyurea treatment will be provided to reduce stroke risk. Hydroxyurea treatment will be started at a fixed dose of 20.0 ± 5.0 mg/kg/day, followed by escalation to maximum tolerated dose (MTD).
Elevated Arm TCD Examination
TCD examination on children with SCA between ages 2 and 16 years of age will be completed to evaluate their risk of stroke. For children with elevated velocities at initial screening or at 1 Year who receive hydroxyurea therapy, TCD examinations will occur every 6 ± 2 months.
Normal Arm TCD Examination
TCD examination on children with SCA between ages 2 and 16 years of age will be completed to evaluate their risk of stroke. TCD examination for all participants will occur at initial screening, at Year 1 (12 ± 3 months), and Year 2 (24 ± 3 months). Children with normal TCD velocities at initial screening will undergo repeat TCD 12 months after enrolment. If the TCD at 12 months has changed to an elevated velocity (conditional or abnormal), the child can begin study treatment (Hydroxyurea).
Locations (2)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Bugando Medical Centre
Mwanza, Tanzania