Protocol

SCATE: Sparing Conversion to Abnormal TCD Elevation (SCATE) - a Phase III clinical trial to compare standard care (observation) with alternative therapy (hydroxyurea) for reducing the risk of converting to an abnormal TCD velocity in children with sickle cell anemia and conditional pre-treatment TCD velocities

Diseases

Hematologic Disorders : Sickle cell anemia

Description

Transcranial Doppler is a medical test that uses sound waves to measure blood flow through the major blood vessels of the brain. The test is most useful at detecting decreased blood flow through narrow areas inside blood vessels; Transcranial Doppler (TCD) is especially useful for monitoring blood flow in the brain of stroke patients who are affected by brain swelling and vasospasm (which are cerebral blood vessel spasms). Abnormal (very high) TCD results are a serious problem for children with sickle cell anemia.Having conditional TCD values means the patient is at greater risk for converting (changing) to an abnormal TCD, and then having an increased risk for stroke.

This study focuses on children who have sickle cell anemia and a recent “conditional” TCD exam; half of the children in this study with conditional TCD exams will receive their normal treatment for sickle cell disease and half will receive the research treatment, hydroxyurea. Hydroxyurea is used to prevent pain episodes and is approved in the United States by the United States Food and Drug Administration (FDA) for adults with sickle cell anemia. Because hydroxyurea is not yet approved for children with sickle cell anemia with conditional TCD, this study is considered research.

Objectives

• To compare Standard Treatment (monthly blood tests and quarterly TCD exams) with Alternative Treatment (hydroxyurea, monthly blood tests and quarterly TCD exams) for maintaining or lowering TCD values, to help prevent strokes that occur in children with abnormal TCD results.
• To compare Standard Treatment to Alternative Treatment for effects on a child’s growth and development, the frequency of medical events (especially ones related to the brain), other sickle-related events, and quality of life.

Eligibility

• Patient should be greater than or equal to 2 years and less than 11 years of age 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
• Patient will not be eligible for the study if they have known allergy to hydroxyurea therapy, HIV infection, current lactation, current participation in other therapeutic clinical trials or pregnancy (for post-menarchal females only)

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE  (1-866-278-5833).

Contact

Jane Hankins MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.