Stroke Prevention in Nigeria 2 Trial

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Jul 23, 2024

Keywords

ClinConnect Summary

The Stroke Prevention in Nigeria 2 Trial is studying the use of hydroxyurea, a medication, to help prevent strokes in children with sickle cell anemia (SCA) who are at high risk. The trial is taking place in various locations in Nigeria and aims to find out how effective this treatment is when given in everyday healthcare settings. The researchers are looking for children between the ages of 5 and 12 who have a specific type of sickle cell disease and have shown signs of being at risk for a stroke, based on ultrasound tests of blood flow in their brains.

To participate, children need to have a confirmed diagnosis of sickle cell disease and must be able to swallow the hydroxyurea capsule. Parents or guardians will need to give permission, and children aged 7 and older will also be asked to agree to join the study. Throughout the trial, participants will receive the hydroxyurea treatment and will be monitored to see how well it works. It is important to note that children with a history of strokes or certain health conditions will not be eligible for this study. This trial is crucial because it aims to find new ways to prevent strokes in young children with sickle cell disease, potentially improving their quality of life and health outcomes.

Gender

ALL

Eligibility criteria

• 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.