The study is about a new treatment for red blood cells (RBCs) to make them safer for transfusions. RBCs are the part of the blood that carries oxygen around the body. The study has two stages. In Stage A, they will test if the new treatment, called the INTERCEPT Blood System, works as well as regular RBCs. In Stage B, they will use the new treatment in places where people might get sick from blood transfusions.
Participants must be 4 years or older and need RBC transfusions due to various conditions like sickle cell disease (SCD) or anemia. They will be randomly assigned to receive either the new or regular RBCs. The study will last for 28 days, with some participants continuing for an extra 6 months. The treatment process involves monitoring vital signs and blood samples before and after transfusions.
Key Points:
- Study lasts up to 28 days, with an optional 6-month extension.
- Participants receive either new or regular RBCs.
- Must be 4 years or older and require RBC transfusions.
Participants will be closely monitored for any side effects or reactions to the treatment. This study aims to make blood transfusions safer, especially in areas at risk for infections like the Zika virus.
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