BACKGROUND: The Spectra Optia (SPO; CaridianBCT) is a new apheresis device based on the COBE Spectra (CSP; CaridianBCT) platform. This study was designed to evaluate the safety and efficiency of the SPO in comparison to the predicate CSP device. STUDY DESIGN AND METHODS: Twenty patients were recruited for a randomized, nonblinded, paired (crossover) clinical trial comparing the SPO to the CSP (pivotal trial). The primary outcome measure was plasma removal efficiency (PRE); secondary outcomes included platelet (PLT) content and hemolysis in the waste plasma, changes in patient cellular counts, patient coagulation and complement cascade activation, accuracy of machine fluid balance measurement, and review of significant adverse events (SAEs). RESULTS:Overall SPO demonstrated 87% PRE with 1.0% PLT loss; these variables were statistically different from CSP (79 and 3.0%, respectively). The accuracy of anticoagulant usage, plasma removal, and fluid replacement as measured by the SPO fluid pumps was 97% or more; fluid balance was within 2% of the measured value. After apheresis there were no statistical changes in patient cellular counts with respect to the initial values. Patient d-dimer and prothrombin fragment 1.2 assays showed no activation of the coagulation system with either device. Measurement of patient C3a, C5a, and plasma free hemoglobin showed no significant differences between the SPO and the CSP. No SAEs were reported. CONCLUSION: The SPO has improved performance characteristics over the CSP. Based on our results, the SPO is acceptable for use in therapeutic plasma exchange programs.
RCT Entities:
BACKGROUND: The Spectra Optia (SPO; CaridianBCT) is a new apheresis device based on the COBE Spectra (CSP; CaridianBCT) platform. This study was designed to evaluate the safety and efficiency of the SPO in comparison to the predicate CSP device. STUDY DESIGN AND METHODS: Twenty patients were recruited for a randomized, nonblinded, paired (crossover) clinical trial comparing the SPO to the CSP (pivotal trial). The primary outcome measure was plasma removal efficiency (PRE); secondary outcomes included platelet (PLT) content and hemolysis in the waste plasma, changes in patient cellular counts, patient coagulation and complement cascade activation, accuracy of machine fluid balance measurement, and review of significant adverse events (SAEs). RESULTS: Overall SPO demonstrated 87% PRE with 1.0% PLT loss; these variables were statistically different from CSP (79 and 3.0%, respectively). The accuracy of anticoagulant usage, plasma removal, and fluid replacement as measured by the SPO fluid pumps was 97% or more; fluid balance was within 2% of the measured value. After apheresis there were no statistical changes in patient cellular counts with respect to the initial values. Patient d-dimer and prothrombin fragment 1.2 assays showed no activation of the coagulation system with either device. Measurement of patientC3a, C5a, and plasma free hemoglobin showed no significant differences between the SPO and the CSP. No SAEs were reported. CONCLUSION: The SPO has improved performance characteristics over the CSP. Based on our results, the SPO is acceptable for use in therapeutic plasma exchange programs.
Authors: Philippe R Bauer; Marlies Ostermann; Lene Russell; Chiara Robba; Sascha David; Bruno L Ferreyro; Joan Cid; Pedro Castro; Nicole P Juffermans; Luca Montini; Tasneem Pirani; Andry Van De Louw; Nathan Nielsen; Julia Wendon; Anne C Brignier; Miet Schetz; Jan T Kielstein; Jeffrey L Winters; Elie Azoulay Journal: Intensive Care Med Date: 2022-08-12 Impact factor: 41.787