Stroke Avoidance for Children in REpublica Dominicana (SACRED): A Prospective Research Study to Reduce Stroke in Children With Sickle Cell Anemia

Locations

1 Dominican Republic site

Age

3 to 15 Years

Genotypes

HbSS

Phase

N/A

Study type

Interventional

Gender

All

Interventions

Drug

Procedure

Compensation

Unknown

About the study

Prospective screening and treatment study for children with Sickle Cell Anemia and increased
stroke risk living in the Dominican Republic.

participation requirements

– Pediatric participants with severe forms of sickle cell anemia (HbSS or HbSβ°
thalassemia)

– Age: between 3.0 and 15.0 years at the time of enrollment

– Parent or guardian willing and able to provide informed consent

– Ability to comply with study related treatments, evaluations, and follow-up

There are no

participation restrictions

applicable to the TCD screening portion of SACRED.

For participants with conditional TCD velocities, the following criteria will disqualify
them from the treatment phase of SACRED:

Exclusion Criteria:

– Known medical condition making participation ill-advised (e.g., acute or chronic
infectious disease including HIV, known allergy to hydroxyurea therapy, or malignancy)

– Abnormal historical laboratory values (most recent pre-enrollment values):

1. Anemia: Hemoglobin concentration < 6.0 gm/dL 2. Reticulocytopenia: Absolute reticulocyte count < 100 x 10˄9/L with a hemoglobin concentration < 8.0 gm/dL 3. Neutropenia: Absolute neutrophil count (ANC) < 1.0 x 10˄9/L 4. Thrombocytopenia: Platelet count < 80 x10˄9 /L 5. Known abnormal renal function (serum creatinine >2X upper limit for age AND ≥ 1.0
mg/dL)

– Pregnancy (for post-menarchal females only)

Locations

  • Santo Domingo, Dominican Republic, Encargada del Servicio de Hematología-Oncología Hospital Infantil Dr. Robert Reid Cabral