Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE)

• Status: Active, not recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Bugando Medical Centre; The American Society of Hematology
• Treatments: Hydroxyurea

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.