Status:
RECRUITING
Stroke Prevention in Nigeria 2 Trial
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Aminu Kano Teaching Hospital
Murtala Muhammed Specialist Hospital
Conditions:
Sickle Cell Disease
Stroke
Eligibility:
All Genders
5-12 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Strokes in sickle cell anemia (SCA), particularly in children living in Africa, are associated with significant morbidity and an increased risk of premature death. In the US, primary stroke prevention...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- The exclusion criteria will be the following:
- 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.
Key Trial Info
Start Date :
August 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06526117
Start Date
August 5 2024
End Date
June 30 2030
Last Update
February 25 2025
Active Locations (2)
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1
Aminu Kano Teaching Hospital
Kano, Nigeria
2
Murtala Muhammad Specialist Hospital
Kano, Nigeria