Transcranial Doppler (TCD) With Transfusions Changing to Hydroxyurea
Status:
Terminated
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
The primary goal of the Phase III TWiTCH trial is to compare 24 months of alternative therapy
(hydroxyurea) to standard therapy (transfusions) for pediatric subjects with sickle cell
anemia and abnormally high (≥200 cm/sec) Transcranial Doppler (TCD) velocities, who currently
receive chronic transfusions to reduce the risk of primary stroke. For the alternative
treatment regimen (hydroxyurea) to be declared non-inferior to the standard treatment regimen
(transfusions), after adjusting for baseline differences, the hydroxyurea-treated group must
have a mean TCD velocity similar to that observed with transfusion prophylaxis.
Phase:
Phase 3
Details
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborators:
Ann & Robert H Lurie Children's Hospital of Chicago Baylor College of Medicine Boston Children's Hospital Boston Children’s Hospital Children's Healthcare of Atlanta Children's Hospital of Philadelphia Children's Hospital of The King's Daughters Children's Hospitals and Clinics of Minnesota Children's National Research Institute Children's Research Institute Columbia University Duke University East Carolina University Medical University of South Carolina National Heart, Lung, and Blood Institute (NHLBI) Nemours Children's Clinic St. Jude Children's Research Hospital State University of New York - Downstate Medical Center Steven and Alexandra Cohen Children's Medical Center Texas Children's Hospital The Hospital for Sick Children University Hospitals Cleveland Medical Center University of Alabama at Birmingham University of Miami University of Mississippi Medical Center University of South Alabama University of Texas Southwestern Medical Center Wayne State University