title: Repetitive large-dose infusion of the novel hydroxyethyl starch 130/0.4 in patients with severe head injury.
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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: *Institute of Anesthesiology and †Division of Surgical Intensive Care, University Hospital, Zurich, Switzerland; ‡Clinical Research Department, Fresenius Kabi, Bad Homburg, Germany.
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Neff
authors.forename: Martin
authors.initials: M
authors.lastname: Doelberg
authors.forename: Cornelius
authors.initials: C
authors.lastname: Jungheinrich
authors.forename: Andrea
authors.initials: A
authors.lastname: Sauerland
authors.forename: Donat R
authors.initials: DR
authors.lastname: Spahn
authors.forename: Reto
authors.initials: R
authors.lastname: Stocker
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002560:Cerebrovascular Circulation / Q000187:drug effects; D006259:Craniocerebral Trauma / Q000188:drug therapy*; D003404:Creatinine / Q000097:blood; D005169:Factor VIII / Q000378:metabolism; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010952:Plasma Substitutes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D016037:Single-Blind Method; D014841:von Willebrand Factor / Q000378:metabolism
chemical_list: D006895:Hydroxyethyl Starch Derivatives; D010952:Plasma Substitutes; D014841:von Willebrand Factor; D005169:Factor VIII; D003404:Creatinine