The reduction of the allogenic transfusion requirement in aortic surgery with a hemoglobin-based solution

Objective: Because of allogenic red blood cell (RBC) availability and infec tion problems, novel alternatives, including hemoglobin-based oxygen-carryi ng solutions (HBOC), are being explored to minimize the perioperative requi rement of RBC transfusions. This study evaluated HBOC-201, a room-temperatu re stable, polymerized, bovine-HBOC, as a substitute for allogenic RBC tran sfusion in patients undergoing elective infrarenal aortic operations. Methods: In a single blind, multicenter trial, 72 patients were prospective ly randomized two-to-one to HBOC (n = 48) or allogenic RBC (n = 24) at the time of the first transfusion decision, either during or after elective inf rarenal aortic reconstruction. Patients randomized to the HBOC group receiv ed 60 g of HBOC for the initial transfusion and had the option to receive t hree more doses (30 g each) within 96 hours. In this group, any further blo od requirement was met with allogenic RBCs. Patients randomized to the allo genic RBC group received only standard RBC transfusions, The efficacy analy sis was a means of assessing the ability of HBOC to eliminate the requireme nt for any allogenic RBC transfusions from the time of randomization throug h 28 days. Safety was evaluated by means of standard clinical trial methods . Results: The two treatment groups were comparable for all baseline characte ristics. Although all patients in the allogenic RBC group required at least one allogenic RBC transfusion, 13 of 48 patients (27%; 95% CI, 15% to 42%) in the HBOC group did not require any allogenic RBC transfusions. The only significant changes documented were a 15% increase in mean arterial pressu re and a three-fold peak increase in serum urea nitrogen concentration afte r HBOC. The complications were similar in both groups, with no allergic rea ctions. There were two perioperative deaths (8%) in the allogenic RBC group and three perioperative deaths (6%) in the:HBOC group (P = 1.0). Conclusion: HBOC significantly eliminated the need for any-allogenic RBC tr ansfusion in 27% of patients undergoing infrarenal aortic reconstruction, b ut did not reduce the median allogenic RBC requirement. HBOC transfusion wa s well tolerated and did not influence morbidity or mortality rates.