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Spectra Optia® Apheresis System
Red Blood Cell Exchange (RBCX)*
Clinical Trial

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
Safety Information

Contraindications

  • No known contraindications for the system's use, except for those associated with all automated apheresis systems
  • The infusion of certain solutions and replacement fluids may be contraindicated in some patients

Possible patient reactions

  • Anxiety, headache, light-headedness, digital and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension and allergic reactions

Reactions to transfused blood products can include1

  • Fever, circulatory overload, shock, allergic reactions, alloimmunization, graft-versus-host disease and transmission of infection

Restricted to prescription use only

  • Operators must be familiar with the system's operating instructions
  • Procedures must be performed by qualified medical personnel
  • A supervisory practitioner may supervise from a physician office or other nonhospital space that is not officially part of the hospital campus as long as he or she remains immediately available2

1AABB (ed.), et al., Circular of Information for the Use of Human Blood and Blood Components. 2006, tenth edition, Council of Europe Publishing, Seattle, WA.

2American Society for Apheresis, "Guidelines for Documentation of Therapeutic Apheresis Procedures in the Medical Record by Apheresis Physicians." Journal of Clinical Apheresis 2007; 22 (3): 183.

*Product and protocol availability varies by country.

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