Hydroxyurea for Stroke Prevention in Children With Sickle Cell Disease in Sub-Saharan Africa

Locations

2 Nigeria sites

Age

1 to 16 Years

Phase

Phase 3

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

About the study

The overall goal of the proposed study is to determine the effectiveness of hydroxyurea
therapy for secondary stroke prevention and prevention of other neurological events in
children with SCA with an acute overt stroke.

participation requirements

– Children ages 1 to 16 years of age with sickle cell anemia confirmed by hemoglobin
electrophoresis evaluation or high performance liquid chromatography (HPLC);

– Informed consent from a parent or legal guardian and assent of participants;

– Children with presence of new stroke up to and including 30 days prior to signing the
informed consent;

– Acceptance of HU therapy for at least three years.

participation restrictions

– Children with history of stroke with event occurring more than 30 days prior to
signing the informed consent;

– Confirmed pregnancy or considering family planning – due to possible
hydroxyurea-induced congenital anomalies or abnormal fetal growth. Adolescents who
have started their menses must have a pregnancy test done every month prior to getting
a prescription for HU;

– Children who are already on blood transfusion or HU therapy;

– Other exclusions: significant cytopenias [absolute neutrophil count (ANC) <1500/ul, platelets <150,000/ul, reticulocytes <80,000/ul, unless Hb is > 9 g/dl], renal
insufficiency (creatinine > 0.8 mg/dl); other significant organ system dysfunction, or
other contraindication to HU therapy; and history of seizures or diagnosis of
epilepsy;

– Other significant organ system dysfunction based on the site investigators discretion;

– Any other condition, such as malnutrition, or chronic illness, which in the opinion of
the site’s Principal Investigator makes study therapy not advisable or unsafe;

– Active infections: bacterial, viral or fungal (tuberculosis, malaria, active
hepatitis, osteomyelitis);

– Active chronic leg ulcers.

Locations

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