NCT03948867
Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE)
Enrolling by Invitation
PHASE2Ages 2–16InterventionalTreatmentChildren's Hospital Medical Center, CincinnatiInvestigator-initiated
~202 participants
Updated 2025-07-17 on ClinicalTrials.gov
What's tested:HydroxyureaElevated Arm TCD ExaminationNormal Arm TCD Examination
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence of Elevated TCD
Measured over Baseline
+1 more outcome measured
Conditions
Where it's being run
2 sites across 2 statesOhio1
Tanzania1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Exclusion
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)
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.
What this trial measures
- Prevalence of Elevated TCDBaseline
Determine 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
- Change in Primary Stroke RiskUp to 12 Months at Month 12
Transcranial Doppler ultrasound (TCD) will be used to measure the change in the TAMV of arterial blood flow in the 4 major intracranial arteries bilaterally from study enrollment to 12 months after study enrollment.