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

Abstract

Hydroxyethyl starch (HES) solutions are effective plasma volume expanders. Impairment of coagulation occurs with large HES volumes infused perioperatively. Therefore, a lower substituted novel HES (Voluven®; Fresenius Kabi, Bad Homburg, Germany) was developed to minimize hemostatic interactions, and was compared with HAES-steril® (Fresenius Kabi) (pentastarch) regarding safety and efficacy. We performed a prospective, randomized, double-blinded study in 100 major orthopedic surgery patients. Because the 95% confidence interval (-330 mL; +284 mL) for the treatment contrast Voluven®-HAES-steril® was entirely included in the predefined equivalence range (± 500 mL), comparable efficacy was established. Voluven® interfered significantly less than HAES-steril® with coagulation factor VIII levels and partial thromboplastin time postoperatively. Total amounts of red blood cells transfused were comparable between the Voluven® and HAES-steril® groups, but a significantly reduced need for homologous red blood cells was observed in the Voluven® group. We conclude that in large-blood-loss surgery, Voluven® has a comparable efficacy with HAES-steril® and may reduce coagulation impairment, possibly leading to a smaller number of allogeneic blood transfusions.