Trial Information

Summary: Dipyridamole/Magnesium to Improve Sickle Cell Hydration

What is the purpose of this study?
The purpose of this study is to determine the benefits as well as side effects of giving drugs called dipyridamole and magnesium to patients with sickle cell anemia (SCA). These drugs are given by mouth and will be taken twice a day by patients with sickle cell disease. The researchers want to see if these drugs will improve the size and weight of the sickle red blood cells in a way that would make the red blood cells less likely to sickle. In the study, the researchers will also measure how long red blood cells live when patients are taking the drugs, and track each patient's overall health.

Who will be included in this study?
Patients who are 12 years old or older and have been diagnosed with sickle cell anemia may be eligible to participate in this study.

Patients may be in part one of this research study for up to three years if not experiencing side effects that are considered dangerous. After patients finish this three-year treatment, they will be asked by the study doctor to visit the office for follow-up exams and/or to be contacted by phone.

Patients do not have to participate in part one in order to participate in part two.

Patients may be in part two of the study for up to four to six months provided the patients do not experience side effects considered dangerous. After patients are finished with this part of the study, the study doctor will ask them to participate in follow-up exams or phone contacts.

Patients will need to have the following exams, tests, or procedures to find out if they can be in the study.

• Medical history
• Physical exam
• Blood tests
• Pregnancy test (for females who could have children)
• Electrocardiogram (ECG)

There may be a direct benefit for patients who agree to take part in this study. Potential benefits may include a decrease in vaso occlusive crisis and decrease in pain episodes. The information learned from this research study may benefit other patients with sickle cell disease in the future.

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.

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

Who should I contact for more information?

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