Stroke Prevention in Nigeria 2 Trial
About this study
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.
- Condition
- Sickle Cell Disease, Stroke
- Tested
- Hydroxyurea
- Sponsor
- Vanderbilt University Medical Center
Who can join
- Age
- 5 to 12 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 5 years
- Maximum age: 12 years
- Study condition: Sickle Cell Disease, Stroke
- 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 7
- 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
2 sites, 2 recruiting
Aminu Kano Teaching Hospital
Kano, Nigeria
Murtala Muhammad Specialist Hospital
Kano, Nigeria
Contact
-
Michael R DeBaun, MD, MPH
615-875-3040 m.debaun@vumc.org
-
Leshana Saint Jean, PHD
615-875-1992 leshana.saint.jean@vumc.org
Potential match only. Final eligibility is determined by the study team.