Objective

To evaluate the performance of the Spectra Optia system RBCX protocols (exchange and depletion/exchange) in adults and children with sickle cell disease

Methodology

Prospective, multi-center, single-arm, open-label study design

Study Population

• Forty adults (≥ 18 years old) and 20 children (≥ 12 but < 18 years old) were a part of the study
• Patients were treated chronically with RBCX
• Patients received a single RBCX either for the initiation of a chronic RBCX program or as a treatment in anticipation of surgery
• More than 60 percent of patients were prophylactically treated with RBCX as part of their primary or secondary stroke prevention treatment

Results

Primary Endpoint

• The Spectra Optia system decreased the percentage of hemoglobin S as expected for the amount of replacement red blood cells administered

Secondary Endpoint

• Post-procedure patient hematocrit was within 1.03 percent (standard deviation of 0.065 percent) of the Spectra Optia system's target

Safety Profile

• No serious adverse events were reported for 72 investigational subjects
• Thirteen of 72 subjects (18.1 percent) experienced at least one apheresis-related adverse event
• Mild to moderate dizziness and nausea were reported most frequently, in 10 of the 13 cases
• Four subjects experienced a decrease in platelet count following the RBCX procedure but did not require transfusion
• There was no difference in the types or severity of adverse events reported for the study's adult and pediatric participants