Sparing Conversion to Abnormal TCD (Transcranial Doppler) Elevation (SCATE)
Status:
Terminated
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy
(hydroxyurea) to standard care (observation) in children with sickle cell anemia and
conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative
regimen (hydroxyurea) to be declared superior to the standard treatment regimen
(observation), the hydroxyurea-treated group must have a three-fold reduction in the
incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard
treatment arm.
Phase:
Phase 3
Details
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborators:
Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti National Heart, Lung, and Blood Institute (NHLBI) St. Jude Children's Research Hospital Tropical Medicine Research Institute