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

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborators: Aminu Kano Teaching Hospital; Murtala Muhammed Specialist Hospital
• Treatments: Hydroxyurea

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.