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CARDIOVASCULAR ANESTHESIA

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

Olivier Langeron, MD^*, Martin Doelberg, PhD, Eng-Than Ang, MD, Francis Bonnet, MD^§, Xavier Capdevila, MD, PhD^||, and Pierre Coriat, MD^*

*Département d’Anesthésie-Réanimation, Centre Hospitalo-universitaire (CHU) Pitié-Salpêtrière, Paris, France; Fresenius Kabi, Fluid Therapy Division, Bad Homburg, Germany; Département d’Anesthésie-Réanimation, Centre Hospitalo-universitaire (CHU) Beaujon, Clichy, France; §Département d’Anesthésie-Réanimation, Centre Hospitalo-universitaire (CHU) Tenon, Paris, France; ||Département d’Anesthésie-Réanimation, Centre Hospitalo-universitaire (CHU) Lapeyronie, Montpellier, France

Address correspondence and reprint requests to O. Langeron, MD, Département d’Anesthésie-Réanimation, Groupe Hospitalier Pitié-Salpêtrière, 47 Boulevard de l’Hôpital, 75651 Paris Cédex 13, France. Address e-mail to olivier.langeron{at}psl.ap-hop-paris.fr

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.

Implications: 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.

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