Evaluation of the AMICUS RBCx System in Sickle Cell Patients

Inclusion Criteria: * Subjects with documented diagnosis of a type of sickle cell disorder who require RBC Exchange or RBC Depletion/Exchange treatment. * Medically stable subjects who have been previously treated for sickle cell disease with RBC Exchange or RBC Depletion/Exchange. * Subjects, or subject's legal representative, who have provided signed informed consent, and assent when applicable, prior to participation. * Adequate availability of sickle trait negative, leukoreduced, Blood type (ABO) blood group, Rhesus factor D (Rh (D)) compatible, unexpired replacement RBC products. * Subjects with sufficient vascular access to accommodate the RBCx procedure as determined by the medical staff responsible for obtaining intravenous access. * Subjects who are able and agree to report adverse events (AEs) during the required reporting period. Exclusion Criteria: * Procedures that occur during acute hospitalization. * Procedures prescribed within one week of discharge of a hospitalization. * Subjects with altered mental status that would prohibit the giving and understanding of informed consent, and assent when applicable, who do not have a legally authorized representative. * Drug abuse, alcohol abuse, or other factors that in the opinion of the investigator could affect the ability of the subject to comply with the requirements of the protocol. * Subjects who have experienced a serious adverse event associated with an RBCx procedure in the past. * In the opinion of the inve…