Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE) (NCT03948867) | Clinical Trial Compass
By InvitationPhase 2
Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE)
United States, Tanzania202 participantsStarted 2019-04-24
Plain-language 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.
Who can participate
Age range2 Years – 16 Years
SexALL
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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.
What they're measuring
1
Prevalence of Elevated TCD
Timeframe: Baseline
2
Change in Primary Stroke Risk
Timeframe: Up to 12 Months at Month 12
Trial details
NCT IDNCT03948867
SponsorChildren's Hospital Medical Center, Cincinnati