Evaluation of a new hydroxyethyl starch solution (HES 130/0.4) in patients undergoing preoperative autologous blood donation

Study Objective: To compare the tolerance and efficacy of the new hydroxyethyl starch (HES) 130/0.4 with a current HES solution (HES 200/0.5) in patients undergoing preoperative autologous blood donation as a model of surgical blood loss. HES 130/0.4 is expected to be a plasma substitute as efficacious as current HES solutions while offering such advantages as more complete renal elimination and reduced tissue storage. Design:, Controlled, randomized, double-blind, phase II clinical trial. Setting: 1500-bed university hospital. Patients: 60 ASA physical status II and III patients scheduled for elective cardiac and noncardiac surgery, and meeting selection criteria for autologous blood donors. Interventions: Collection of 500 mL of blood with simultaneous intravenous (IV) infusion of 500 mL of either HES 130/0.4 or HES 200/0.5 (mean molecular weight 130 kD and 200 kD, degree of substitution 0.4 and 0.5, respectively). Measurements: Noninvasive measurements of heart rate and arterial blood pressure were obtained every 5 minutes until 1 hour after blood donation and infusion of the study drugs; laboratory studies (complete blood counts, electrolytes, markers of renal and liver function) were performed; and follow-up assessment of adverse events was undertaken by questionnaire 24 hours after blood donation and infusion of the study drugs. Main Results: Both hemodynamics and laboratory test results did not differ significantly between the groups at any time. Hemodynamics remained stable in each group, and no adverse event was observed in any patient until one hour after blood donation and infusion of the study drugs. Adverse events elicited by postphlebotomy questionnaire were mild and probably unrelated to HES infusion. Conclusions: Intravenous infusion of 500 nil of the new HES 130/0.4 was tolerated well and maintained cardiovascular stability in patients undergoing preoperative autologous blood donation. HES 130/0.4 proved equivalent to HES 200/0.5 in every measured respect. Its pharmacokinetic profile may render HES 130/0.4 an attractive alternative to current HES solutions. (C) 2001 by Elsevier Science Inc.