Prospective screening and treatment study for children with Sickle Cell Anemia and increased
stroke risk living in the Dominican Republic.
Procedure: TCD examination
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Full eligibility criteria for NCT02769845
Ages eligible for Study
3 Years to 15 Years
Genders eligible for Study
Accepts Healthy Volunteers
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 exclusion criteria 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:
Known medical condition making participation ill-advised (e.g., acute or chronic infectious disease including HIV, known allergy to hydroxyurea therapy, or malignancy)
Reticulocytopenia: Absolute reticulocyte count < 100 x 109/L with a hemoglobin concentration < 8.0 gm/dL
Neutropenia: Absolute neutrophil count (ANC) < 1.0 x 109/L
Thrombocytopenia: Platelet count < 80 x 109/L
Known abnormal renal function (serum creatinine >2X upper limit for age AND ≥ 1.0 mg/dL)
Pregnancy (for post-menarchal females only)
All locations for NCT02769845
Dominican Republic (1)
Encargada del Servicio de Hematología-Oncología Hospital Infantil Dr. Robert Reid Cabral
Santo Domingo, Dominican Republic
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View full eligibility
Tris trial is registered with FDA with number: NCT02769845. The sponsor of the trial is Children's Hospital Medical Center, Cincinnati and it is looking for 500 volunteers for the current phase.
Official trial title: Stroke Avoidance for Children in REpublica Dominicana (SACRED): A Prospective Research Study to Reduce Stroke in Children With Sickle Cell Anemia
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