Hydroxyurea to Prevent Stroke in Children With Sickle Cell Anemia and Elevated TCD Flow Velocity

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess prospectively the efficacy of hydroxyurea therapy in the setting of cerebrovascular disease, manifest as conditional or abnormal transcranial doppler ultrasonography (TCD) flow velocities, in children with sickle cell anemia (SCA). TCD is used to measure flow velocity in intracranial arteries as a marker of increased stroke risk in children with SCA. The primary objective of this protocol is to determine whether hydroxyurea reduces elevated TCD velocity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Hydroxyurea

Criteria

Inclusion Criteria:

• Children with Sickle Cell Anemia

• Aged 3 to 18 years

• Confirmed TCD velocity greater than or equal to 140cm/sec

• Negative serum pregnancy test for subjects of childbearing potential

• Decline transfusions (for subjects with TCD velocity greater than or equal to 200 cm/sec)