NCT03948867Active, not recruitingPhase 2
Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE)
Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE): A Prospective Trial to Reduce Primary Stroke in Children With Sickle Cell Anaemia
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 202 (actual)
- First submitted
- 8 Feb 2019
- Start date
- 24 Apr 2019
- Primary completion date
- 5 Sept 2022
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Stroke, Sickle cell disease
- NCT number
- NCT03948867
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 202
- From 24 Apr 2019 to the primary completion date, 5 Sept 2022
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- Previous history of stroke.
Other illness
- Febrile illness within the past two weeks. (Temporary Exclusion)
- Known medical condition making participation ill-advised.
- Known allergic reactions to components of hydroxyurea.
Lab values
- Abnormal pre-enrolment laboratory values (Temporary Exclusion)
Other
- 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:
- Hospitalized within the past two weeks. (Temporary Exclusion)
- Currently pregnant or lactating.
Who the study is looking for
- 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.
Age in the registry: 2 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bugando Medical Centre Coordinator of this site? Confirm its status | Mwanza | Tanzania | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.