Evaluation of the AMICUS RBCx System in Sickle Cell Patients

The goal of Red Blood Cell Exchange is to remove a patient's red blood cells (RBCs) and replace the blood volume removed with either healthy donor RBCs and/or colloid/crystalloid solutions. Depending on the RF used, the procedure can be considered an RBC Exchange or RBC Depletion/Exchange procedure. The RBC Depletion/Exchange procedure is a modification of the RBC Exchange procedure. The AMICUS RBCx protocol provides the ability to use various RFs including healthy donor RBCs or a combination of fluids, such as saline followed by RBCs. In RBC Exchange and the exchange portion of the RBC Depletion/Exchange procedures, RBC units are used as the RF, while colloid and/or crystalloid solutions are used as the RF in the depletion portion of the RBC Depletion/Exchange procedures. A new operating protocol on the AMICUS Separator that enables the device to perform Red Blood Cell Exchange (RBCx) procedures in accordance with the replacement fluid(s) (RF) prescribed by a physician for patients with sickle cell disease

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 investigator, subjects who have a life expectancy fewer than 30 days.
• Subjects who refuse blood products.
• Subjects who are pregnant.
• Subjects who fail to comply with site requirements for cessation of medication that interfere or increase procedure risk.