Journal Mobile Options
Table of Contents
Vol. 33, No. 3, 2003
Issue release date: May–June 2003
Pathophysiol Haemost Thromb 2003;33:121–126
(DOI:10.1159/000077819)

Influence of a Long-Term, High-Dose Volume Therapy with 6% Hydroxyethyl Starch 130/0.4 or Crystalloid Solution on Hemodynamics, Rheology and Hemostasis in Patients with Acute Ischemic Stroke

Results of a Randomized, Placebo-Controlled, Double-Blind Study

Woessner R.a · Grauer M.T.a · Dieterich H.-J.b · Bepperling F.c · Baus D.c · Kahles T.d · Georgi S.d · Bianchi O.d · Morgenthaler M.a · Treib J.a
aDepartment of Neurology, Westpfalz Klinikum, University City of Kaiserslautern, Kaiserslautern, bDepartment of Anaesthesiology, University of Tübingen, Tübingen, cDepartment of Clinical Research, Fresenius Kabi, Deutschland GmbH, Bad Homburg, dDepartment of Neurology, University of the Saarland, Homburg/Saar, Germany
email Corresponding Author


 goto top of outline Key Words

  • Stroke
  • Hydroxyethyl starch
  • Cardiac output
  • Blood pressure

 goto top of outline Abstract

Background: This study was performed to investigate the clinical effects of a 4-day volume therapy with a newly developed, 6% hydroxyethyl starch (HES) 130/0.4 versus crystalloid solution, with particular regard to systemic and cerebral hemodynamics, rheology and safety. Methods: In a randomized, double-blind study, 40 patients suffering from an acute ischemic stroke received either 6% HES 130/0.4 or crystalloid solution as continuous infusion over 4 days with a total dose of 6.5 liters. Efficacy parameters studied included hemodynamics (cardiac output, blood pressure, flow velocity with transcranial Doppler) and rheology (hematocrit and plasma viscosity). Safety parameters examined included laboratory, hemostaseology (including factor VIII) and an adverse event questionnaire (including pruritus). Results: In both groups, a small, but not significant increase in cardiac output was observed. There were no significant changes regarding the remaining efficacy or safety parameters, except for the well-known increase in serum alpha-amylase through the infusion of HES. Conclusion: In our study with patients suffering from acute ischemic stroke, continuous infusion (1 ml/min) of HES 130/0.4 or crystalloid solution did not differ regarding safety or hemodynamic efficacy.

Copyright © 2003 S. Karger AG, Basel


 goto top of outline References
  1. Baron J-F, Treib J (eds): Volume Replacement. Berlin, Springer, 1998.
  2. Treib J (ed): Volume Therapy. Berlin, Springer, 2000.
  3. Treib J, Grauer MT, Woessner R, Morgenthaler M: Treatment of stroke on an intensive stroke unit: A novel concept. Intensive Care Med 2000;26:1598–1611.
  4. Mast H, Marx P: Neurological deterioration under isovolemic hemodilution with hydroxyethyl starch in acute cerebral ischemia. Stroke 1991;22:680–683.
  5. Haemodilution in acute stroke: Results of the Italian haemodilution trial. Italian Acute Stroke Study Group. Lancet 1988;i:318–321.
  6. Aichner FT, Fazekas F, Brainin M, Polz W, Mamoli B, Zeiler K: Hypervolemic hemodilution in acute ischemic stroke: The Multicenter Austrian Hemodilution Stroke Trial (MAHST). Stroke 1998;29:743–749.
  7. Koller M, Haenny P, Hess K, Weniger D, Zangger P: Adjusted hypervolemic hemodilution in acute ischemic stroke. Stroke 1990;21:1429–1434.
  8. Strand T: Evaluation of long-term outcome and safety after hemodilution therapy in acute ischemic stroke. Stroke 1992;23:657–662.
  9. Strand T, Asplund K, Eriksson S, Hägg E, Lithner F, Wester PO: A randomized controlled trial of hemodilution therapy in acute ischemic stroke. Stroke 1984;15:980–989.
  10. Hypervolemic hemodilution treatment of acute stroke. Results of a randomized multicenter trial using pentastarch. The Hemodilution in Stroke Study Group. Stroke 1989;20:317–323.
  11. Kaplan S, Park TS, Gonzales E, Gidday J: Hydroxyethyl starch reduces leukocyte adherence and vascular injury in the newborn pig cerebral circulation after asphyxia. Stroke 2000;31:2218–2223.
  12. Treib J, Baron JF, Grauer MT, Strauss RG: An international view of hydroxyethyl starches. Intensive Care Med 1999;25:258–268.
  13. Treib J, Haass A, Pindur G: Coagulation disorders caused by hydroxyethyl starch. Thromb Haemost 1997;78:974–983.
  14. Treib J, Haass 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;36:450–455.
  15. Treib J, Haass A, Pindur G, Seyfert UT, Treib W, Grauer MT, Jung F, Wenzel E, Schimrigk K: HES 200/0.5 is not HES 200/0.5. Influence of the C2/C6 hydroxyethylation ratio of hydroxyethyl starch (HES) on hemorheology, coagulation and elimination kinetics. Thromb Haemost 1995;74:1452–1456.
  16. Treib J, Haass A, Krammer I, Stoll M, Grauer MT, Schimrigk K: Cardiac output in patients with acute stroke. J Neurol 1996;243:575–578.
  17. Rudolf J: Hydroxyethyl starch for hypervolemic hemodilution in patients with acute ischemic stroke: A randomized, placebo-controlled phase II safety study. Cerebrovasc Dis 2002;14:33–41.
  18. Waitzinger J, Bepperling F, Pabst G, Opitz J, Müller M, Baron JF: 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;16:151–160.
  19. Waitzinger J, Bepperling F, Pabst G, Opitz J, Fackelmeyer 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;17:119–125.
  20. Waitzinger J, Bepperling F, Pabst G, Opitz J: Hydroxyethyl starch (HES) [130/0.4], a new HES specification: Pharmacokinetics and safety after multiple infusions of 10% solution in healthy volunteers. Drug R D 2003;4:149–157.
  21. Langeron O, Doelberg M, Ang ET, Bonnet F, Capdevila X, Coriat P: 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. Anesth Analg 2001;92:855–862.
  22. Leuschner J, Opitz J, Winkler A, Scharpf R, Bepperling F: Tissue storage of 14C-labelled hydroxyethyl starch (HES 130/0.4) and HES 200/0.5 after repeated intravenous administration to rats. Drugs R D 2003;4:331–338.
  23. Gröchenig E, Albegger K, Dieterich HJ, et al: Hydroxyethylstarch-related pruritus: A prospective multicenter investigation of 544 patients. Perfusion 1998;11:62–69.

 goto top of outline Author Contacts

Priv.-Doz. Dr. med. Johannes Treib, MD
Department of Neurology
Westpfalz-Klinikum GmbH, University Teaching Hospital
DE–67655 Kaiserslautern (Germany)
Tel. +49 631 203 1792, Fax +49 631 203 1977, E-Mail jtreib@westpfalz-klinikum.de


 goto top of outline Article Information

Received: May 16, 2003
Accepted after revision: September 24, 2003
Number of Print Pages : 6
Number of Figures : 0, Number of Tables : 3, Number of References : 23


 goto top of outline Publication Details

Pathophysiology of Haemostasis and Thrombosis
(Formely: Haemostasis)
Official Journal of the ‘Mediterranean League against Thromboembolic Diseases’

Vol. 33, No. 3, Year 2003 (Cover Date: May-June 2003)

Journal Editor: J. Rosing, Maastricht
ISSN: 1424–8832 (print), 1424–8840 (Online)

For additional information: http://www.karger.com/pht


Copyright / Drug Dosage / Disclaimer

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.