Early access
Sign in
Taking people in NigeriaPhase 4

Hydroxyurea to Prevent Stroke in Children With Sickle Cell Disease in Nigeria

Tests hydroxyurea to prevent stroke in children with sickle cell disease.

Key facts

Who runs it
Vanderbilt University Medical Center
Where
Kano, NigeriaSee the 2 sites
Trial code
Registry title
Stroke Prevention in Nigeria 2 Trial
Status
Recruiting
Phase
Phase 4
People taking part
220 people, planned
Started
5 Aug 2024
Expected to end
30 Jun 2030
Type of study
Interventional
Treatments tested
  • Hydroxyurea
Record updated
5 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 5 to 12 years with sickle cell anemia (HbSS or HbSB0) in Nigeria who are at high risk of stroke. It tests hydroxyurea to help prevent a first stroke.

Age
5 to 12 years (the check can take place up until the 13th birthday)
Sex
All sexes can join.
Disease stage
Sickle cell anemia (HbSS or HbSB0) confirmed by a blood test (HPLC), with high blood-flow speed in the brain on TCD scans: two readings of 180 cm/sec or more and under 220 cm/sec, or one reading of 220 cm/sec or more.
Earlier treatment
Children cannot already be on blood transfusion or hydroxyurea treatment.
Biomarker or test result
TCD flow velocity readings as described above; HbSS or HbSB0 confirmed by HPLC.

Main reasons for not taking part

  • Earlier stroke or TIA, or signs of moderate or severe nerve problems
  • Other serious organ problems or any reason hydroxyurea cannot be used
  • Already on blood transfusion or hydroxyurea
  • Very low blood counts, or kidney problems (creatinine above 0.8 mg/dl (71 µmol/L))
  • History of seizures or epilepsy, or metal in the body that makes MRI unsafe

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior stroke or TIA by history, or concern for moderate or severe neurological deficit based on a positive validated "10 questions" screening
  • 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
  • The exclusion criteria will be the following:
  • Other significant organ system dysfunction or other contraindication to hydroxyurea

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 5 and 12 years old?

Where in Nigeria

  • Aminu Kano Teaching HospitalKano, NigeriaContact: Shehu U Abdullahi, MD, FWACPaedTaking people
  • Murtala Muhammad Specialist HospitalKano, NigeriaContact: Salma A Suwaid, MBBS FWACPTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Low or Moderate Dose HydroxyureaTreatment being tested

    Initial treatment with Hydroxyurea at 10 mg/kg/day (range 7 to 15 mg/kg/day) for primary stroke prevention. Subsequent treatment with moderate-dose hydroxyurea (20 mg/kg/day (range 17.5 - 26 mg/kg/day)) based after at least two severe pain events requiring physician contact during the trial.

    Treatment: Hydroxyurea

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II: A Multicenter, Open-label, Single-arm Type I Hybrid Clinical Trial
Plain-language title
Hydroxyurea to Prevent Stroke in Children With Sickle Cell Disease in NigeriaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06526117, who can take part
Record updated
5 March 2026