Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE)
Enrolling by invitation · Phase 2
Conditions studied: Sickle Cell Anemia in Children
In brief
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.
Key facts
- Study ID
- NCT03948867
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 202
- Starts
- 2019-04-24
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-07-17
Who can join
Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Willingness to sign informed consent
- Willingness to follow all study procedures
- Available for study visits for the duration of the study and no plans to move away from study center.
- Confirmed diagnosis of Sickle Cell Anemia (SCA) by haemoglobin electrophoresis.
- Able to take oral medication and follow hydroxyurea treatment schedule.
You may not qualify if…
- There are no permanent exclusion criteria for participants to enroll in the screening TCD portion of SPHERE. Temporary, time-limited exclusion criteria for the screening TCD portion include the following:
- Febrile illness within the past two weeks. (Temporary Exclusion)
- Hospitalized within the past two weeks. (Temporary Exclusion)
- Transfusion within the past two weeks. (Temporary Exclusion)
- Patients who enroll in the screening portion, have a conditional or abnormal TCD, and are eligible to start hydroxyurea will be excluded from receiving study treatment if they meet any of the following criteria:
- Abnormal pre-enrolment laboratory values (Temporary Exclusion)
- Known medical condition making participation ill-advised.
- Known allergic reactions to components of hydroxyurea.
- Previous history of stroke.
- Currently pregnant or lactating.
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Bugando Medical Centre — Mwanza, Tanzania
Full record on ClinicalTrials.gov
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