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Randomized Controlled Trial Comparative Study Clinical Trial
The efficacy and safety of the new heparin-induced extracorporeal low-density lipoprotein precipitation system (Plasmat Futura) in comparison with the currently used system (Plasmat Secura).
- Frithjof Blessing, Ying Wang, Dorothea Nagel, and Dietrich Seidel.
- Institut für Klinische Chemie, Ludwig-Maximilians-University, Munich, Germany. frithjof.blessing@klch.med.uni-muenchen.de
- Ther Apher Dial. 2004 Feb 1; 8 (1): 33-8.
AbstractThe aim of the present study was to examine whether the recently introduced heparin-mediated extra-corporeal low-density lipoprotein precipitation (HELP) apheresis system Plasmat Futura (since 2001) was comparable to Plasmat Secura system, used to date, in its efficiency to remove atherogenic components, its ease of handling and operating as well as clinical safety and patient compliance. Coronary heart disease (CHD) patients (N = 21) were first treated with Plasmat Secura system and 13 of them were then randomly switched over to the upgraded Plasmat Futura system. Eight patients remained on Secura system. All together, 40 Futura treatments and 40 Secura treatments were performed. Blood samples were collected immediately before and after each apheresis therapy. Our data showed no significant differences in the reduction of plasma low-density lipoprotein, lipoprotein (a) and fibrinogen by Plasmat Futura and Secura system (P > 0.05). However, the major advantages of Plasmat Futura system are the ready-to-use sterile dialysis solutions instead of reverse osmosis device in Plasmat Secura, which ensures flexibility and lower risk of cross infections. Long-term tolerance and safety parameters showed no significant difference (P > 0.05). On the basis of our studies. Plasmat Futura system is easy to use, shows no adverse events and is comparable to Plasmat Secura in its capacity to remove proatherogenic plasma factors.
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