A randomized crossover study comparing membrane and centrifugal therapeutic plasma exchange procedures

Area of Science:

• Nephrology
• Hematology
• Medical Devices

Background:

• Therapeutic plasma exchange (TPE) is a critical procedure with two main system types: membrane-based (mTPE) and centrifuge-based (cTPE).
• Limited comparative studies exist for TPE devices, particularly for the membrane-based Diapact and centrifuge-based Spectra Optia systems.
• This study provides the first randomized data comparing the Diapact (mTPE) and Spectra Optia (cTPE) devices.

Purpose of the Study:

• To conduct the first randomized head-to-head comparison of membrane-based (Diapact) and centrifuge-based (Spectra Optia) therapeutic plasma exchange systems.
• To evaluate and compare the plasma removal efficiency (PRE), total procedure time, and removal efficiencies of blood cells, IgG, and fibrinogen between the two TPE systems.
• To assess the safety and adequacy of TPE procedures performed on both devices.

Main Methods:

• A randomized prospective study involving 27 patients comparing mTPE (Diapact) and cTPE (Spectra Optia) systems.
• Standardized TPE procedures were performed on both devices.
• Key metrics analyzed included plasma removal efficiency (PRE), total procedure time (including setup and priming), and removal efficiencies for blood cells, IgG, and fibrinogen.

Main Results:

• Both systems achieved adequate plasma removal, but the Spectra Optia (cTPE) was significantly faster, with a mean procedure time of 101.5 minutes compared to 157 minutes for the Diapact (mTPE).
• The Spectra Optia demonstrated higher plasma removal efficiency (83.0%) than the Diapact (53.2%).
• While IgG and blood cell removal efficiencies were similar, the Spectra Optia was more effective at removing fibrinogen (72.3%) compared to the Diapact (62.9%).

Conclusions:

• Both membrane-based (Diapact) and centrifuge-based (Spectra Optia) systems are safe and adequate for therapeutic plasma exchange.
• The Spectra Optia system offers significantly shorter procedure times and higher plasma removal efficiency compared to the Diapact system.
• The findings suggest the Spectra Optia may be a more efficient choice for TPE procedures requiring substantial plasma removal.