Study Objective: The study aims to evaluate the safety and effectiveness of red blood cells (RBCs) treated with the INTERCEPT Blood System, a special process that reduces harmful germs, compared to regular RBCs in patients who need blood transfusions.
Study Details: The study is divided into two stages. In Stage A, patients will be randomly assigned to receive either the test RBCs or regular RBCs for up to 28 days, with an optional extension for 6 months for those with long-term conditions like sickle cell disease. In Stage B, the program will be extended to regions at risk for Zika virus infections, after reviewing Stage A results with the FDA (Food and Drug Administration, the US agency that ensures the safety of food and medicine).
Eligibility: To participate, patients must be 4 years or older, require blood transfusion, and meet certain health criteria. Pregnant women or those with certain blood conditions may not be eligible.
- Length of Study: Up to 28 days, with an optional 6-month extension.
- Visits Needed: Regular monitoring and follow-ups for safety assessments.
- Risks: Potential side effects related to blood transfusions, which will be monitored closely.