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
Vanderbilt University Medical Center
220 participants
Aug 5, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria5
- Prior stroke or TIA by history, or concern for moderate or severe neurological deficit based on a positive validated "10 questions" screening;
- Other significant organ system dysfunction or other contraindication to hydroxyurea;
- Children who are already on therapy with either blood transfusion or hydroxyurea therapy;
- 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
- 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.
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Interventions
The study intervention will include initial treatment with low-dose hydroxyurea therapy at 10 mg/kg/day (range 7 - 15 mg/kg/day), with subsequent increase to moderate dose hydroxyurea therapy at 20 mg/kg/day (range 17.5 - 26 mg/kg/day) after at least two severe events requiring physician contact.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06526117