Hydroxyurea trial aims to stop strokes in african kids with sickle cell

NCT ID NCT06526117

Prevention Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether hydroxyurea, a drug already used for sickle cell disease, can prevent strokes in 220 high-risk children in Nigeria. Children with sickle cell anemia and abnormal blood flow in the brain will receive low then moderate doses of hydroxyurea. The goal is to see if this treatment reduces stroke or mini-stroke rates in real-world clinics.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Hydroxyurea (a drug that helps reduce sickle cell complications)
What this could lead to: If successful, this could provide a simple, low-cost way to prevent strokes in children with sickle cell disease in Africa, where resources are limited.
What could go wrong: This is a single-arm trial (no comparison group), so results may be less definitive. Hydroxyurea can cause side effects like low blood counts, and long-term benefits are not yet proven in this setting.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

sickle cell disease stroke disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sickle cell disease Stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Hydroxyurea trial aims to stop strokes in african kids with sickle cell

What the study statuses mean