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โ† Trials
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Stroke Prevention in Nigeria 2 Trial

RecruitingPhase 4Ages 5 Years - 12 YearsAllVanderbilt University Medical Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 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 Criteria: 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.
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What it tests

  • Hydroxyurea
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Where

2 sites
Aminu Kano Teaching Hospital
Kano, Nigeria
Murtala Muhammad Specialist Hospital
Kano, Nigeria
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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