Helping find treatment alternatives for children with sickle cell disease
The primary goal of Stroke With Transfusions Changing to Hydroxyurea (SWiTCH), a Phase III study, is to compare two therapies for the prevention of secondary stroke and treatment of iron overload in children with sickle cell anemia, a disease in which blocked blood vessels may cause pain, serious infection, and organ damage. This cutting-edge research will compare the standard therapy of transfusion and chelation to hydroxyurea and phlebotomy for the prevention of stroke and reduction of iron overload, respectively. Hydroxyurea has not been approved for use in children with sickle cell anemia and stroke, but it has been used to prevent painful episodes in children and adults with sickle cell anemia. Phlebotomy helps lower iron levels through the intravenous removal of blood.
As head of the statistical and data coordinating center, Rho provides operational and statistical leadership, protocol development, case report form development, site management, clinical monitoring, clinical data management, data monitoring committee and steering committee support, progress and statistical reporting, and final clinical study report and manuscript preparation. Ron Helms (Ph.D., Chairman) is the principal investigator (PI), and Nancy Yovetich (Ph.D., Research Scientist) is the co-PI. The study sponsor is the National Heart, Lung, and Blood Institute.
For more information about this research from ClinicalTrials.gov, please see below.