Voluven (R), a lower substituted novel hydroxyethyl starch (HES 130/0.4), causes fewer effects on coagulation in major orthopedic surgery than HES 200/0.5

Hydroxyethyl starch (HES) solutions are effective plasma volume expanders. Impairment of coagulation occurs with large PIES volumes infused perioperat ively. Therefore, a lower substituted novel HES (Voluven (R); Fresenius Kab i, Bad Homburg, Germany) was developed to minimize hemostatic interactions, and was compared with HAES-steril (R) (Fresenius Kabi) (pentastarch) regar ding safety and efficacy. We performed a prospective, randomized, double-bl inded study in 100 major orthopedic surgery patients. Because the 95% confi dence interval (-330 mL; +284 mL) for the treatment contrast Voluven (R) -H AES-steril (R) was entirely included in the predefined equivalence range (/- 500 mt), comparable efficacy was established. Voluven (R) interfered sig nificantly less than HAES-steril (R) with coagulation factor VIII levels an d partial thromboplastin time postoperatively. Total amounts of red blood c ells transfused were comparable between the Voluven (R) and HAES-steril (R) groups, but a significantly reduced need for homologous red blood cells wa s observed in the Voluven (R) group. We conclude that in large-blood-loss s urgery, Voluven (R) has a comparable efficacy with HAES-steril (R) and may reduce coagulation impairment, possibly leading to a smaller number of allo geneic blood transfusions.