Stroke Prevention in Nigeria 2 Trial

Recruiting now · Phase 4

Conditions studied: Sickle Cell Disease, Stroke

In brief

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.

Key facts

Study ID

NCT06526117

Run by

Vanderbilt University Medical Center

People needed

220

Starts

2024-08-05

Expected to finish

2030-06-30

Last updated by the study team

2026-03-05

Who can join

Age: 5 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Aminu Kano Teaching Hospital — Kano, Nigeria (enrolling)
• Murtala Muhammad Specialist Hospital — Kano, Nigeria (enrolling)

Full record on ClinicalTrials.gov

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