Does HBOC-201 (hemopure) affect platelet function in orthopedic surgery: A single-site analysis from a multicenter study

HBOC-201, Hemoglobin glutamer-250 (bovine), (Biopure Corp., Cambridge, MA) has been studied in an international, multicenter, pivotal Phase III trial. A subset analysis of use of blood products indicated that the HBOC-201 group required no more than the packed red blood cell (PRBC) group and was limited to less than 6% in both treatment groups. In a subset analysis from one site, platelet function using PFA-100 was assessed before and after transfusion, and compared those receiving HBOC-201 versus PRBC. After initial IRB approval, patient consent for the Phase III trial and blood draws for PFA-100, an additional IRB exemption for retrospective chart review was obtained. cEPI and cADP means were compared at seven time periods: true baseline(before starting surgery and anesthesia), before transfusion, after transfusion, 1 day, 2 days, 3 to 9 days and 21 or more days after transfusion. Twenty-seven (HBOC: n = 12, PRBC: n = 15) subjects were studied. Comparing data from before transfusion and baseline did not show statistically significant differences in any of cEPI or cADP measurements. cEPI means for the HBOC-201 group increased after transfusion compared to the true baseline (P = 0.01), before transfusion (P = 0.0004) and day 1 after transfusion (P = 0.002). cADP means for the HBOC-201 group were greater after transfusion compared to the true baseline (P = 0.05) and before transfusion (P = 0.005). In the PRBC group there were no significant difference in cEPI and cADP means between all of the time periods. Our study shows that HBOC-201 causes mild platelet dysfunction. Although there were significant changes after HBOC infusion and cEPI and cADP mean values were above the upper normal limit, they did not reach the non-closure time. Further controlled studies are needed to establish definitively the effects that HBOC-201 has on platelet function in patients.