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


METHODS
Controlled, randomized, double-blind, phase II clinical trial.


METHODS
1500-bed university hospital.


METHODS
60 ASA physical status II and III patients scheduled for elective cardiac and noncardiac surgery, and meeting selection criteria for autologous blood donors.


METHODS
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).


METHODS
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.


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 mL 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.
Kasper
S M
SM
Department of Anesthesiology, University of Cologne, 50924 Cologne, Germany. stefan-mario.kasper@medizin.uni-koeln.de
Strömich
A
A
Kampe
S
S
Radbruch
L
L
D000328:Adult; D000368:Aged; D016063:Blood Loss, Surgical / Q000517:prevention & control; D001804:Blood Transfusion, Autologous; D004311:Double-Blind Method; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000009:adverse effects / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D012996:Solutions
D006895:Hydroxyethyl Starch Derivatives; D012996:Solutions