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Active Not Recruiting
NCT03948867
Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE)
Conditions: Sickle Cell Anemia in Children
Sex: All
Ages: 2 Years – 16 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 202
Sponsor: Children's Hospital Medical Center, Cincinnati
Location: Cincinnati Children's Hospital Medical Center Cincinnati Ohio
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.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
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.
Source: ClinicalTrials.gov (NCT03948867). StuddyBuddy aggregates publicly available trial information.