NCT06526117RecruitingPhase 4
Stroke Prevention in Nigeria 2 Trial
Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II: A Multicenter, Open-label, Single-arm Type I Hybrid Clinical Trial
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
The primary goal of this study is to complete a multicenter single-arm, type I hybrid trial to assess the effectiveness of hydroxyurea therapy for primary stroke prevention in high-risk children with sickle cell anemia (SCA) living in Nigeria in routine care settings.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 23 Jul 2024
- Start date
- 5 Aug 2024
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Stroke, Sickle cell disease
- NCT number
- NCT06526117
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 220
- From 5 Aug 2024 to the primary completion date, 31 Dec 2029
- 2 sites in 1 country
- 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
- Prior stroke or TIA by history, or concern for moderate or severe neurological deficit based on a positive validated "10 questions" screening;
- Children who are already on therapy with either blood transfusion or hydroxyurea therapy;
Lab values
- Significant cytopenias (absolute neutrophil count (ANC) \<1500, platelets \<150,000/ul, reticulocytes \<80,000/ul, unless Hb is \> 9 g/dl\], renal insufficiency (creatinine \> 0.8 mg/dl); and
Age
- History of seizures or diagnosis of epilepsy, and 6) metal in the body that would make MRI unsafe. The rationale for excluding children under 5 years old: Despite being a vulnerable age group for strokes, children younger than 5 years were excluded because a significant proportion of this population is unable to swallow a capsule, the only stable form of hydroxyurea available in Nigeria.
Other
- The exclusion criteria will be the following:
- Other significant organ system dysfunction or other contraindication to hydroxyurea;
Who the study is looking for
- The inclusion criteria for the SPRING-2 Trial will consist of:
- Diagnosis of HbSS or HbSB0 confirmed by high-performance liquid chromatography (HPLC);
- Informed consent from the parent/legal guardian and assent from the patient at least 7 years of age;
- Two TCD flow velocity readings of \>or equal to180 cm/sec and \< 220 cm/sec or one TCD velocity reading \> or equal to 220 cm/sec; typically the repeat TCD is performed on the same day so treatment can start immediately;
- Age between 5 and 12 years (assessment can take place up until the 13th birthday), which includes the peak age of onset of strokes in SCA, \~ 6 yo; and
- Ability to swallow the hydroxyurea capsule.
Age in the registry: 5 years to 12 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 |
|---|---|---|---|
| Murtala Muhammad Specialist Hospital Coordinator of this site? Confirm its status | Kano | Nigeria | Recruiting |
| Aminu Kano Teaching Hospital Coordinator of this site? Confirm its status | Kano | Nigeria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.