Abstract
Purpose: To compare the new hydroxyethyl starch HES 130/0.4 (Voluven®) and the standard HES 200/0.5 (pentastarch) regarding effectiveness for plasma volume substitution and safety of large volumes in heart surgery.
Methods: Fifty-nine patients scheduled for coronary artery bypass grafting were enrolled in a prospective, randomised, double-blind, parallel-group, multicentre, clinical, phase III study. Hydroxyethyl starch was used as the exclusive artificial colloid for acute normovolemic hemodilution, priming of the heart lung machine, and for intra- and postoperative plasma volume substitution from induction of anesthesia until 16 hr after the end of surgery. Efficacy was evaluated by comparing the amount of colloid infused, hemodynamics, and colloid osmotic pressure (COP). Safety endpoints were blood loss, the use of allogeneic blood products, coagulation variables, and adverse events.
Results: Effectiveness, as assessed by the total amount of infused HES volumes within the treatment period, was similar between HES 130/0.4 and HES 200/0.5 (2550 mL±560 mL vs 2466 mL ±516 mL). Also, no differences were found for the use of other colloids (pasteurised plasma), hemodynamics, and COP. In HES 130/0.4 patients, the postoperative increase of von-Willebrand factor (vWF) was higher (P<0.01), blood loss was lower, and less packed red blood cells were transfused.
Conclusion: Hydroxyethyl starch 130/0.4 is an effective plasma volume expander in heart surgery and may be used as the sole artificial colloid to cover the perioperative period. We found a reduced influence of HES 130/0.4 on the physiologic postoperative increase of vWF.
Résumé
Objectif: Comparer le nouvel hydroxyéthylamidon HEA 130/0,4 (Voluven®) et l’HEA standard 200/0,5 (pentamidon) au plan de l’efficacité, quand on l’utilise comme substitution du volume plasmatique, et au plan sécuritaire de l’emploi de volumes importants en cardiochirurgie.
Méthode: Cinquante-neuf patients qui devaient subir un pontage aorto-coronarien ont participé à une étude clinique multicentrique, prospective, randomisée, à double insu et en groupes parallèles, de phase Ill. L’hydroxyéthylamidon a été utilisé comme colloïde artificiel exclusif pour l’hémodilution normovolémique pratiquée d’emblée, pour amorcer l’utilisation du coeur-poumon artificiel et pour le remplacement du volume plasmatique peropératoire et postopératoire depuis l’induction de l’anesthésie jusqu’à 16 h après la fin de l’opération. L’efficacité a été évaluée en comparant la quantité de colloïde perfusé, l’hémodynamie et la pression osmotique du colloïde (POC). Les paramètres mesurés ont été: la perte sanguine, l’utilisation de produits sanguins allogéniques, les variables de coagulation et les inconvénients.
Résultats: L’efficacité, évaluée selon la quantité totale d’HEA perfusé pendant le traitement, a été similaire pour l’HEA 130/0,4 et l’HEA 200/0,5 (2550 mL±561 mL vs 2466 mL±516 mL). De plus, il n’y a eu aucune différence quant à l’utilisation d’autres colloïdes (plasma pasteurisé), à l’hémodynamie et à la POC. Chez les patients qui ont reçu l’HEA 130/0,4, l’augmentation postopératoire du facteur de von Willebrand (vWF) a été plus élevée (P<0,01), la perte sanguine plus faible et la transfusion de globules rouges concentrés moins importante.
Conclusion: L’hydroxyéthylamidon 130/0,4 représente un substitut du plasma sanguin efficace en cardiochirurgie et peut être utilisé comme colloïde artificiel unique pendant la période périopératoire complète. Nous avons constaté une action réduite de l’HEA 130/0,4 sur l’augmentation physiologique postopératoire du vWF.
Article PDF
Similar content being viewed by others
References
Tabuchi N, de Haan J, Gallandat Huet RCG, Boonstra PW, van Oeveren W. Gelatin use impairs platelet adhesion during cardiac surgery. Thromb Haemost 1995; 74: 1447–51.
Tigchelaar I, Gallandat Huet RCG, Korsten J, Boonstra PW, van Oeveren W. Hemostatic effects of three colloid plasma substitutes for priming solution in cardiopulmonary bypass. Eur J Cardiothorac Surg 1997; 11: 626–32.
Laxenaire MC, Charpentier C, Feldmann L. Réactions anaphylactoides aux substituts colloidaux du plasma: incidence, facteurs de risque, mécanismes. Ann Fr Anesth Réanim 1994; 13: 301–10.
Ferber HP, Nitsch E, Förster H. Studies on hydroxyethyl starch. Arnzeim Forsch / Drug Res 1985; 35: 615–22.
Förster H. Physical and chemical properties of hydroxyethyl starches.In: Baron J-F (Ed.). Plasma Volume Expansion. Paris: Arnette, 1992: 105–32.
Stump DC, Strauss RG, Henriksen RA, Petersen RE, Saunders R. Effects of hydroxyethyl starch on blood coagulation, particularly factor VIII. Transfusion 1985; 25: 349–54.
Lockwood DNJ, Bullen C, Machin SJ. A severe coagulopathy following volume replacement with hydroxyethyl starch in a Jehovah’s witness. Anaesthesia 1988; 43: 391–3.
Kapiotis S, Quehenberger P, Eichler H-G, et al. Effect of hydroxyethyl starch on the activity of blood coagulation and fibrinolysis in healthy volunteers: comparison with albumin. Crit Care Med 1994; 22: 606–12.
Strauss RG, Stansfield C, Henriksen RA, Villhauer PJ. Pentastarch may cause fewer effects on coagulation than hetastarch. Transfusion 1988; 28: 257–60.
Treib J, Haass A, Pindur G Coagulation disorders caused by hydroxyethyl starch. Thromb Haemost 1997; 78: 974–83.
Mishler JM IV. Pharmacology of Hydroxyethyl Starch. New York, Toronto: Oxford University Press 1982.
Waitzinger J, Bepperling F, Pabst G, Opitz J, Müller M, Baron J-F. Pharmacokinetics and tolerability of a new hydroxyethyl starch (HES) specification (HES 130/0.4) after single-dose infusion of 6% or 10% solutions in healthy volunteers. Clin Drug Invest 1998; 16: 151–60.
Waitzinger J, Bepperling F, Pabst G, Opitz J, Fackelmayer A, Boldt J. Effect of a new hydroxyethyl starch (HES) specification 6% HES (130/0.4) on blood and plasma volumes after bleeding in 12 healthy male volunteers. Clin Drug Invest 1999; 17: 119–25.
Bepperling F, Opitz J, Waitzinger J, Pabst G, Müller M, Baron JF. HES 130/0.4, a new HES specification: pharmacokinetics after multiple infusions of 10% solutions in healthy volunteers. (Abstract) Crit Care 1999; 3: 77.
Bepperling F, Opitz J, Leuschner J. HES 130/0.4, a new HES specification: tissue storage after multiple infusions in rats. (Abstract) Crit Care 1999; 3: 76–7.
Vogt N, Drück A, Wohlfeld C, Otten H, Georgieff M. Wirkung und Nebenwirkung von 6%iger HES 130/0.4 im Vergleich mit 6%iger HES 200/0.5 als Plasmaersatz bei endoprothetischen Eingriffen. (Abstract) Anästhesiol Intensivmed Notfallmed Schmerzther 1998; 33: 162.
Langeron O, Hbitz D, Faure E, Marty J, Coriat P. Volume replacement during major orthopedic surgery: a new 6% hydroxyethyl starch solution (HES 130/0.4) might reduce blood loss. (Abstract) Br J Anaesth 1999; 82: 74.
Konrad CJ, Markl TJ, Schuepfer GK, Schmeck J, Gerber HR. In vitro effects of different medium molecular hydroxyethyl starch solutions and lactated Ringer’s solution on coagulation using sonoclot. Anesth Analg 2000; 90: 274–80.
Kasper S-M, Strömich A, Golla U, Wixforth J. Safety and tolerance of a novel formulation of hydroxyethyl starch (HES 130/0.4) in patients undergoing autologous blood donation with isovolemic volume replacement. (Abstract) Br J Anaesth 1998; 80: 84–5.
Treib J, Haas A, Pindur G, Grauer MT, Wenzel E, Schimrigk K. All medium starches are not the same: influence of the degree of hydroxyethyl substitution of hydroxyethyl starch on plasma volume, hemorrheologic conditions and coagulation. Transfusion 1996; 36: 450–5.
Cope JT, Banks D, Mauney MC, et al. Intraoperative hetastarch infusion impairs hemostasis after cardiac operations. Ann Thorac Surg 1997; 63: 78–83.
Brown RS, Thwaites BK, Mongan PD. Tranexamic acid is effective in decreasing postoperative bleeding and transfusions in primary coronary artery bypass operations: a doubleblind, randomized, placebo-controlled trial. Anesth Analg 1997; 85: 963–70.
Hawkey CJ, Stirling Y, Chakrabarti R, Brozovic M, Cox AG, Meade TW. Haemostatic changes following surgery. Thromb Res 1983; 32: 223–7.
Claes Y, Van Hemelrijck J, Van Gerven M, et al. Influence of hydroxyethyl starch on coagulation in patients during the perioperative period. Anesth Analg 1992; 75: 24–30.
Macintyre E, Mackie IJ, Ho D, Tinker J, Bullen C, Machin SJ. The haemostatic effects of hydroxyethyl starch (HES) used as a volume expander. Intensive Care Med 1985; 11: 300–3.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Gallandat Huet, R.C.G., Siemons, A.W., Baus, D. et al. A novel hydroxyethyl starch (Voluven®) for effective perioperative plasma volume substitution in cardiac surgery. Can J Anesth 47, 1207–1215 (2000). https://doi.org/10.1007/BF03019870
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/BF03019870