Paired comparison of therapeutic plasma exchange using the Fenwal Amicus versus TerumoBCT Spectra Optia.

PURPOSE

Terumo BCT Spectra Optia (O) and Fenwal Amicus (A) can perform therapeutic plasma exchange (TPE). We compared these systems in a prospective, randomized, crossover study of 81 paired procedures. Primary objective was to determine if there was a difference in platelet loss between the instruments. Secondary objectives were to determine differences in procedure time (PT), plasma removal efficiency (PRE 1), plasma removal rate (PRR), and fluid balance (FB).

METHODS

Fifty-seven adults undergoing 162 procedures were included. Diagnoses included neurologic, nephrologic, and hematologic diseases. Replacement fluids included 5% normal serum albumin and/or fresh frozen plasma. The first instrument (randomized) established the inlet flow rate for the second with a maximum inlet rate of 120 ml/min. Spun HCT was used to program the procedure. One plasma volume was exchanged, for both instruments. Multivariable general estimating equations were used to assess the relationship between the outcome variables with machine after adjusting for covariates, with P values <.05 significant.

RESULTS

Median total blood volume (4,775 mL-A, 4,775 mL-O) and preprocedure spun HCT (33%-A, 34%-O) were not statistically different. The plasma removed (3196 mL-A, 3120 mL-O), PLT in waste plasma (0.62 × 10 -A, 0.33 × 10 -O), PLT decline (8.5%-A, 6.5%-O), and PRR (48.1 mL/min-A, 49.2 mL/min-O) were not statistically different. There were statistically significant, but clinically irrelevant, differences in PLT CE1 (6.2%-A, 3.6%-O), PRE 1 (85.3%-A, 83.9%-O), FB (+2 mL-A,+15 mL-O), and PT (71 min-A, 71 min-O).

CONCLUSIONS

Statistical differences were seen but none were of a magnitude to be clinically relevant, indicating comparable TPE performance.