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

Study Objective: To compare the tolerance and efficacy of the new hydroxyet hyl starch (HES) 130/0.4 with a current HES solution (HES 200/0.5) in patie nts undergoing preoperative autologous blood donation as a model of surgica l blood loss. HES 130/0.4 is expected to be a plasma substitute as efficaci ous as current HES solutions while offering such advantages as more complet e 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 autolog ous 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 molecula r weight 130 kD and 200 kD, degree of substitution 0.4 and 0.5, respectivel y). Measurements: Noninvasive measurements of heart rate and arterial blood pressure were obtained every 5 minutes until 1 hour after blood donation a nd infusion of the study drugs; laboratory studies (complete blood counts, electrolytes, markers of renal and liver function) were performed; and foll ow-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 h our after blood donation and infusion of the study drugs. Adverse events el icited 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 tol erated well and maintained cardiovascular stability in patients undergoing preoperative autologous blood donation. HES 130/0.4 proved equivalent to HE S 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 b y Elsevier Science Inc.