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Hematologic Disorders : Sickle cell disease
For children with sickle cell anemia, chronic transfusions are given to reduce the risk of stroke. Transfusions work well to lower the velocities and lower the risk of stroke, but have serious side effects including iron overload, developing antibodies or getting an infection. Pilot data suggests that hydroxyurea significantly lowers TCD velocities in children with sickle cell anemia. Also, hydroxyurea treatment can prevent other events like acute chest syndrome. However it is not known if hydroxyurea will be as good as blood transfusions to prevent stroke.
The primary goal of the TWiTCH trial is to compare 24 months of alternative therapy (hydroxyurea) to standard therapy (transfusions) for children with sickle cell anemia and abnormal TCD velocities, who currently receive chronic transfusions for the prevention of primary stroke. For the alternative treatment schedule (hydroxyurea) to be declared at least as good as the standard treatment regimen (transfusions), after adjusting for baseline differences, the hydroxyurea-treated group must have similar outcomes to that observed with the transfusions. TWiTCH is a multi-center study.
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).
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)
Referring or consulting physicians only: firstname.lastname@example.org
For all other inquiries about St. Jude Children's Research Hospital studies: email@example.com
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.