Trial Information

Summary: Silent Infarct Transfusion Trial (SITT)

What is the purpose of this study?
The goals of this study are to:

• Find children who have sickle cell anemia and who can join a study to find out if blood transfusions can prevent new brain injuries known as strokes or silent infarcts. Both are brain injuries resulting from a lack of blood flow in the brain
• Find children who have sickle cell anemia and who can join a study to find if blood transfusion therapy can prevent new brain injury from lack of blood flow such as stroke or silent infarct
• Find children who have sickle cell anemia and who can join a study to find if blood transfusion therapy can help mental growth
• Find out if blood transfusions can prevent brain injury

Who will be included in this study?
Patients who are 6 years old to 12 years old with sickle cell disease may be eligible for participation in this study.

What is involved?
Patients may be in this study for up to 3.5 years if they are not experiencing side effects that are considered dangerous.

Patients will need to have the following exams, tests, or procedures during the study. If patients have had some of the tests recently, they may not need to be repeated. This will be up to the study doctor.

• Learning and thinking tests
• Medical history
• Physical examination
• Blood tests
• HIV test
• Hepatitis C test
• Pregnancy test (for females old enough to have children)
• MRI
• Neurology test
• Transcranial Doppler exam

What are the benefits?
There may or may not be a direct benefit for patients who agree to take part in this study. The potential benefit is that the transfusion therapy may prevent recurring strokes. This study may help choose better treatments for future patients with sickle cell anemia. Children with sickle cell anemia and silent strokes who receive blood transfusion therapy may maintain their IQ scores better than those who do not receive blood transfusion therapy.

Will I get all the facts about the study?
Parents interested in having their child participate will be scheduled with a physician who will thoroughly explain all of the details of the study. The physician will review the consent form with the parent/patient and will be sure that all questions are answered. The consent form goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns and more. Study procedures will not begin until a parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.

What are the risks?
A detailed list of side effects will be provided to those patients interested in knowing more about the study.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.