Preventing strokes in children with sickle cell disease in Nigeria using hydroxyurea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the effectiveness of hydroxyurea therapy for preventing strokes in high-risk children with sickle cell anemia living in Nigeria. It is a multicenter, open-label, single-arm trial that will assess children aged 5 to 12 years who have elevated Transcranial Doppler (TCD) velocities. The study addresses the challenges of traditional stroke prevention methods, such as blood transfusions, which are not feasible in low-resource settings. By utilizing hydroxyurea, the trial seeks to provide a safer and more accessible option for stroke prevention in this vulnerable population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Aminu Kano Teaching Hospital
  Kano, Nigeria Recruiting
• Murtala Muhammad Specialist Hospital
  Kano, Nigeria Recruiting

Study contacts

• Principal investigator: Michael R DeBaun, MD, MPH — Vanderbilt University Medical Center
• Study coordinator: Michael R DeBaun, MD, MPH
• Email: m.debaun@vumc.org
• Phone: 615-875-3040

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.