Use of an oxygen therapeutic as an adjunct to intraoperative autologous donation to reduce transfusion requirements in patients undergoing coronary artery bypass graft surgery.
BACKGROUND
The benefits of intraoperative autologous donation (IAD) in reducing the need for allogeneic blood transfusion in surgery have been debated for several years. The purpose of this study was to determine if IAD alone or in conjunction with hemoglobin raffimer (HR) confers a reduction in red cell or blood component transfusion compared with results in standard clinical practice.


METHODS
The Phase III clinical trial was a multicenter, randomized, double-blind study to determine the efficacy and safety of HR versus 10% pentastarch when used to facilitate IAD in 299 patients undergoing primary coronary artery bypass grafting. The patients received HR or pentastarch as an adjunct to IAD immediately before cardiopulmonary bypass. Results were compared with transfusion requirements for 150 matched patients in the reference group.


RESULTS
The frequency of allogeneic RBC transfusion in the HR, pentastarch, and reference groups was 56%, 76%, and 95%, respectively. The number of allogeneic red cell units used was 49 in the HR group, 104 in the pentastarch group, and 480 in the reference group (p < 0.001). The total number of non-RBC units administered was 150 in the HR group, 238 in the pentastarch group, and 270 in the reference group.


CONCLUSIONS
In this study, patients treated with HR in conjunction with IAD received fewer transfusions overall and a lower volume of allogeneic RBCs and non-RBC allogeneic blood products than did the two comparison groups. This confers a real benefit on the overall blood supply by decreasing use and increasing availability.
Department of Surgery, The Miriam Hospital, Providence, RI 02906, USA.
A Gerson
AG
Greenburg
Hae W
HW
Kim
D000368:Aged; D001802:Blood Substitutes / Q000008:administration & dosage / Q000009:adverse effects; D001803:Blood Transfusion / Q000706:statistics & numerical data; D001804:Blood Transfusion, Autologous / Q000706:statistics & numerical data; D001026:Coronary Artery Bypass / Q000379:methods*; D023921:Coronary Stenosis / Q000097:blood / Q000601:surgery*; D004311:Double-Blind Method; D017707:Erythrocyte Transfusion / Q000706:statistics & numerical data; D005260:Female; D006454:Hemoglobins / Q000008:administration & dosage*; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives; D008297:Male; D008875:Middle Aged; D011887:Raffinose / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D001802:Blood Substitutes; D006454:Hemoglobins; D006895:Hydroxyethyl Starch Derivatives; C097124:O-raffinose cross-linked human hemoglobin; D011887:Raffinose