Red Blood Cell Exchange Clinical Trial

Therapeutic apheresis on Spectra Optia

Objective

To evaluate the performance of the Spectra Optia™ Apheresis 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% of patients were prophylactically treated with RBCX as part of their primary or secondary stroke prevention treatment.

Results

Primary endpoint

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

• Post-procedure patient hematocrit was within 1.03% (standard deviation of 0.065%) 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%) 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.

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