Effect of a new hydroxyethy1 starch HES 130/0.4 [voluven] compared with HES 200/0.5 on coagulation in major orthopedic surgery

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. A prospective randomized double-blinded study was performed on 100 major orthopedic surgery patients. Because of 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 transfusion 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. It was concluded that in large-blood-loss surgery, Voluven has a comparable efficacy with HAES-steril and may reduce coagulation impairment possibly leading to a similar number of allogenic blood transfusion