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Clinical Trial
. 2003 May;96(5):1453-1459.
doi: 10.1213/01.ANE.0000061582.09963.FD.

Repetitive large-dose infusion of the novel hydroxyethyl starch 130/0.4 in patients with severe head injury

Thomas A Neff  1 , Martin Doelberg, Cornelius Jungheinrich, Andrea Sauerland, Donat R Spahn, Reto Stocker
Affiliations
Clinical Trial

Repetitive large-dose infusion of the novel hydroxyethyl starch 130/0.4 in patients with severe head injury

Thomas A Neff et al. Anesth Analg. 2003 May.

Abstract

In this prospective, controlled, randomized, single-center study, we investigated the safety of repetitive large-dose infusion of a novel hydroxyethyl starch solution (6% HES 130/0.4) in cranio-cerebral trauma patients. Patients were randomized to receive either HES 130/0.4 (n = 16) at repetitive doses of up to 70 mL x kg(-1) x d(-1) (which is the largest HES dose reported in the literature) or the control HES 200/0.5 (n = 15) up to its approved dose limit of 33 mL x kg(-1) x d(-1) followed by human albumin up to a total dose (HES 200/0.5 + albumin) of 70 mL x kg(-1) x d(-1). We found no differences between groups in mortality, renal function, bleeding complications, and use of blood products. There were also no major differences in coagulation variables. However, at some time points, factor VIII, von Willebrand factor, and ristocetin cofactor were higher in the HES 130/0.4 group despite the large HES doses administered. We conclude that HES 130/0.4 can safely be used in critically ill head trauma patients over several days at doses of up to 70 mL x kg(-1) x d(-1).

Implications: There are concerns that infusion of certain hydroxyethyl starch (HES) types for plasma volume expansion may influence coagulation and renal function. We investigated the safety of the novel HES 130/0.4 in patients with severe cranio-cerebral trauma. The repetitive HES doses administered in this study are the largest reported in the literature.

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References

    1. Marik PE, Varon J, Trask T. Management of head trauma. Chest 2002; 122: 699–711.
    1. Brain Trauma Foundation, American Association of Neurological Surgeons, Joint Section on Neurotrauma and Critical Care. Guidelines for the management of severe head injury. J Neurotrauma 1996; 13: 641–734.
    1. Langeron O, Doelberg M, Ang ET, et al. 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: 855–62.
    1. Gallandat Huet RC, Siemons AW, Baus D, et al. A novel hydroxyethyl starch (Voluven®) for effective perioperative plasma volume substitution in cardiac surgery. Can J Anaesth 2000; 47: 1207–15.
    1. Haisch G, Boldt J, Krebs C, et al. The influence of intravascular volume therapy with a new hydroxyethyl starch preparation (6% HES 130/0.4) on coagulation in patients undergoing major abdominal surgery. Anesth Analg 2001; 92: 565–71.

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