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.
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.


CONCLUSIONS
Hydroxyethyl starches are common plasma volume expanders, but may interfere with coagulation at large doses. We tested a novel hydroxyethyl starch specification (Voluven; Fresenius Kabi, Bad Homburg, Germany) which was developed to reduce hemostatic interactions while preserving its efficacy in restoring plasma volume in comparison to HAES-steril (pentastarch; Fresenius Kabi) in major orthopedic surgery.
Département d'Anesthésie-Réanimation, Centre Hospitalo-universitaire (CHU) Pitié-Salpêtrière, Paris, France.
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D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001777:Blood Coagulation / Q000187:drug effects*; D016063:Blood Loss, Surgical / Q000517:prevention & control; D003102:Colloids / Q000627:therapeutic use; D004311:Double-Blind Method; D023381:Endpoint Determination; D017707:Erythrocyte Transfusion; D005260:Female; D006400:Hematocrit; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000009:adverse effects* / Q000737:chemistry; D008297:Male; D008875:Middle Aged; D019637:Orthopedic Procedures; D010952:Plasma Substitutes / Q000009:adverse effects*; D010953:Plasma Volume; D011446:Prospective Studies; D000516:alpha-Amylases / Q000097:blood
D003102:Colloids; D006895:Hydroxyethyl Starch Derivatives; D010952:Plasma Substitutes; D000516:alpha-Amylases