Biomaterial Database

Volume replacement therapy during major orthopedic surgery using Voluven (hydroxyethyl starch 130/0.4) or hetastarch. 2007

Sweeta D Gandhi, and Richard B Weiskopf, and Cornelius Jungheinrich, and Robert Koorn, and Diane Miller, and Robert E Shangraw, and Donald S Prough, and Daniela Baus, and Frank Bepperling, and David C Warltier

Department of Anesthesiology, Clement J. Zablocki Veterans Affairs Medical Center and the Medical College of Wisconsin, Milwaukee, Wisconsin 53226, USA. sdgandhi@mcw.edu

BACKGROUND The purpose of this study was to test the equivalence of efficacy and compare the safety of the 6% hydroxyethyl starches (HES) Voluven (HES 130/0.4; Fresenius Kabi, Bad Homburg, Germany) and hetastarch (HES 670/0.75 in saline) for intravascular volume replacement therapy during major orthopedic surgery. METHODS In a prospective, controlled, randomized, double-blind, multicenter trial of patients undergoing major orthopedic surgery, 49 patients were treated with HES 130/0.4 and 51 patients were treated with hetastarch. Infusion of colloids was guided by central venous and arterial blood pressures. The primary efficacy endpoint was the volume of colloid solution infused; the primary safety endpoints were calculated total erythrocyte loss, the nadir factor VIII activity, and the nadir von Willebrand factor concentration within 2 h of completion of surgery. RESULTS The total volume of colloid solution required for intraoperative volume replacement did not differ between HES 130/0.4 and hetastarch (1,613+/-778 [SD] ml for HES 130/0.4 and 1,584+/-958 ml for hetastarch). The nadir factor VIII activity within 2 h of the end of surgery was lower for hetastarch than for HES 130/0.4 (P=0.0499); for those who received greater than 1,000 ml colloid, the nadir factor VIII activity and von Willebrand factor concentration within 2 h of end of surgery were lower for hetastarch than for HES 130/0.4 (P=0.0487 and P=0.008, respectively). CONCLUSIONS Voluven (HES 130/0.4) and hetastarch are equally efficacious plasma volume substitutes; however, HES 130/0.4 has a lesser effect on coagulation.

UI	MeSH Term	Description	Entries
D007430	Intraoperative Care	Patient care procedures performed during the operation that are ancillary to the actual surgery. It includes monitoring, fluid therapy, medication, transfusion, anesthesia, radiography, and laboratory tests.	Care, Intraoperative
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D010952	Plasma Substitutes	Any liquid used to replace blood plasma, usually a saline solution, often with serum albumins, dextrans or other preparations. These substances do not enhance the oxygen- carrying capacity of blood, but merely replace the volume. They are also used to treat dehydration.	Blood Expanders,Plasma Volume Expanders,Expanders, Blood,Expanders, Plasma Volume,Substitutes, Plasma,Volume Expanders, Plasma
D001794	Blood Pressure	PRESSURE of the BLOOD on the ARTERIES and other BLOOD VESSELS.	Systolic Pressure,Diastolic Pressure,Pulse Pressure,Pressure, Blood,Pressure, Diastolic,Pressure, Pulse,Pressure, Systolic,Pressures, Systolic
D001810	Blood Volume	Volume of circulating BLOOD. It is the sum of the PLASMA VOLUME and ERYTHROCYTE VOLUME.	Blood Volumes,Volume, Blood,Volumes, Blood
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005169	Factor VIII	Factor VIII of blood coagulation. Antihemophilic factor that is part of the factor VIII/von Willebrand factor complex. Factor VIII is produced in the liver and acts in the intrinsic pathway of blood coagulation. It serves as a cofactor in factor X activation and this action is markedly enhanced by small amounts of thrombin.	Coagulation Factor VIII,Factor VIII Clotting Antigen,Factor VIII Coagulant Antigen,Factor VIII Procoagulant Activity,Thromboplastinogen,Blood Coagulation Factor VIII,F VIII-C,Factor 8,Factor 8 C,Factor Eight,Factor VIIIC,Hyate-C,Hyatt-C,F VIII C,Hyate C,HyateC,Hyatt C,HyattC
D005260	Female		Females
D005440	Fluid Therapy	Therapy whose basic objective is to restore the volume and composition of the body fluids to normal with respect to WATER-ELECTROLYTE BALANCE. Fluids may be administered intravenously, orally, by intermittent gavage, or by HYPODERMOCLYSIS.	Oral Rehydration Therapy,Rehydration,Rehydration, Oral,Oral Rehydration,Rehydration Therapy, Oral,Therapy, Fluid,Therapy, Oral Rehydration,Fluid Therapies,Oral Rehydration Therapies,Oral Rehydrations,Rehydration Therapies, Oral,Rehydrations,Rehydrations, Oral,Therapies, Fluid,Therapies, Oral Rehydration