SACRED A Prospective Research Study to Reduce Stroke in Children With Sickle Cell Anemia

• Status: Active, not recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: Hospital Infantil Dr. Robert Reid Cabral
• Treatments: Hydroxyurea

Criteria

Inclusion Criteria:

• 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:

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)